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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Lisa Erickson, MPH - 10-CBA@ndmp.org
McCarty, John, M.
NCT01351545
HM13913
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Inclusion Criteria:
* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
* Pediatric and adult patients of any age
Exclusion Criteria:
* Patients who are receiving only licensed CBUs
* Cord blood transplant recipients at international transplant centers
* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated DRUG: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia
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Show 141 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Rushang Patel, MD - (rushang.patel.md@adventhealth.com) |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| All Children's Hospital St. Petersburg, Florida | Deepakbabu Chellapandian, MD - (dchella2@jhmi.edu) |
| Amarillo Blood and Marrow Transplant Program Amarillo, Texas | |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Sonali Chaudhury, MD - (schaudhury@luriechildrens.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | Jason Farrar, MD - (JEFarrar@uams.edu) |
| Avera Transplant Institute Sioux Falls, South Dakota | Waqas Jehangir, MD, FACP - (waqas.jehangir@avera.org) |
| Banner MD Anderson Cancer Center Gilbert, Arizona | September Mitchell, RN - (september.mitchell@bannerhealth.com) Rajneesh Nath, MD - (rajneesh.nath@bannerhealth.com) |
| Beth Israel Deaconess Boston, Connecticut | |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | Deepika Bhatla, MD - (dbhatla@slu.edu) |
| Children's Healthcare of Atlanta Atlanta, Georgia | Ann Haight, MD - (Ann.haight@choa.org) |
| Children's Hospital Colorado Aurora, Colorado | Michael Verneris, MD - (MICHAEL.VERNERIS@CUANSCHUTZ.EDU) |
| Children's Hospital and Research Center of Oakland Oakland, California | Mark Walters, MD - (mwalters@mail.cho.org) |
| Children's Hospital at Montefiore The Bronx, New York | Mahvish Rahim, MD - (mrahim@montefiore.org) |
| Children's Hospital of Los Angeles Los Angeles, California | Neena Kapoor, MD - (nkapoor@chla.usc.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Sureyya Savasan, MD - (ssavasan@med.wayne.edu) |
| Children's Hospital of New Orleans/LSUHSC New Orleans, Louisiana | Lolie Yu, MD - (lyu@lsuhsc.edu) |
| Children's Hospital of Orange County (CHOC) Orange, California | Rishikesh Chavan, MD - (rishikesh.chavan@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Nancy Bunin, MD - (buninn@email.chop.edu) |
| Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | Paul Szabolcs, MD - (Paul.szabolcs@chp.edu) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | David Margolis, MD - (dmargoli@mcw.edu) |
| Children's Medical Center Dallas Dallas, Texas | Victor Aquino, MD - (Victor.aquino@utsouthwestern.edu) |
| Children's Mercy Hospital and Clinics Kansas City, Missouri | |
| Children's National Medical Center Washington D.C., District of Columbia | David Jacobsohn, MD - (dajacobs@childrensnational.org) |
| Childrens Hospital Medical Center of Akron Akron, Ohio | Megan Sampson, MD - (msampson@akronchildrens.org) |
| Cincinnati Children's Hospital Cincinnati, Ohio | Stella Davies, MD - (stella.davies@cchmc.org) |
| City of Hope Duarte, California | Monzr Al Malki, MD - (malmalki@coh.org) |
| Cleveland Clinic Cleveland, Ohio | Craig Sauter, MD - (sauterc@ccf.org) |
| Cohen Children's Medical Center of New York New Hyde Park, New York | Jonathan Fish, MD - (jfish1@nshs.edu) |
| Columbia University Medical Center - Morgan Stanley Children's Hospital New York, New York | Monica Bhatia, MD - (mb2476@columbia.edu) |
| Cook Children's Hospital Fort Worth, Texas | Gretchen Eames, MD - (gretchen.eames@cookchildrens.org) |
| Dana Farber Cancer Institute Boston, Massachusetts | Corey Cutler, MD - (cscutler@partners.org) |
| Duke University Medical Center Durham, North Carolina | Joanne Kurtzberg, MD - (kurtz001@mc.duke.edu) |
| Emory University Hospital Atlanta, Georgia | |
| Florida Center for Pediatric Cellular Therapy Orlando, Florida | Susan Kelly, MD - (susan.kelly.md@flhosp.org) |
| Fred Hutchinson Cancer Research Center Seattle, Washington | Ann Dahlberg, MD - (adahlber@fredhutch.org) |
| Greenebaum Cancer Center - University of Maryland Baltimore, Maryland | |
| H Lee Moffitt Cancer Center Tampa, Florida | |
| Hackensack University Medical Center Hackensack, New Jersey | Alfred Gillio, MD - (agillio@humed.com) |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | Troy Quigg, MD - (troy.quigg@spectrumhealth.org) |
| Henry Ford Health System Jackson, Michigan | Nalini Janakiraman, MD - (njanaki1@hfhs.org) |
| Indiana Blood & Marrow Transplantation Beech Grove, Indiana | Luke Akard, MD - (lakard@ibmtindy.com) |
| Indiana University/Riley Hospital for Children Indianapolis, Indiana | Jodi Skiles, MD - (jskiles@iu.edu) |
| Johns Hopkins Baltimore, Maryland | Allen Chen, MD, PhD - (allenchen@jhmi.edu) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | Randal Wada, MD - (randalw@hawaii.edu) |
| Karmanos Cancer Institute Detroit, Michigan | |
| Levine Children's Hospital Charlotte, North Carolina | Jeffrey Huo, MD - (Jeffrey.Huo@carolinashealthcare.org) Michelle Hyland - (Michelle.Hyland@carolinashealthcare.org) |
| Loma Linda University Cancer Center Loma Linda, California | Hisham Abdel-Azim, MD - (habdelazim@llu.edu) |
| Loyola University Medical Center Maywood, Illinois | Patrick Stiff, MD - (pstiff@lumc.edu) |
| M.D. Anderson Cancer Center Houston, Texas | Elizabeth Shpall, MD - (eshpall@mdanderson.org) |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | Vivek Roy, MD - (roy.vivek@mayo.edu) |
| Mayo Clinic Arizona (adults) Phoenix, Arizona | James Slack, MD - (slack.james@mayo.edu) |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Medical City Dallas Dallas, Texas | Vikas Bhushan, MD - (vikas.bhushan@usoncology.com) |
| Medical College of Georgia Augusta, Georgia | Claude Sportes, MD - (csportes@gru.edu) |
| Medical College of Wisconsin Milwaukee, Wisconsin | Hamadani Mehdi, MD - (mhamadani@mcw.edu) |
| Medical University of South Carolina Charleston, South Carolina | Michelle Hudspeth, MD - (hudspeth@musc.edu) |
| Memorial Sloan-Kettering Cancer Center New York, New York | Ioannis Politikos, MBBS - (politiki@mskcc.org) |
| Methodist Healthcare Blood and Marrow Transplant Center Memphis, Tennessee | Fnu Kaweeta, MD - (fnu.kaweeta@mlh.org) Joshua Boss, RN - (fnu.kaweeta@westclinic.com) |
| Methodist Healthcare System of San Antonio/Texas Transplant Institute San Antonio, Texas | Jose Cruz, MD - (josecarlos.cruz@hcahealthcare.com) |
| Midwestern Regional Medical Center Zion, Illinois | |
| Mount Sinai Medical Center Miami Beach, Florida | Alla Keyzner, MD - (alla.keyzner@mssm.edu) |
| NIH/NCI Bethesda, Maryland | |
| Nationwide Children's Hospital Columbus, Ohio | Rolla Abu-Arja, MD - (rolla.abu-arja@nationwidechildrens.org) |
| Nemours - Alfred I. duPont Hospital for Children Brandywine, Delaware | Emi Caywood, MD - (ecaywood@nemours.org) |
| Nemours Children's Hospital - Mayo Jacksonville Jacksonville, Florida | Michael Joyce, MD - (mjoyce@nemours.org) |
| New York Presbyterian Hospital at Cornell New York, New York | Tsiporah Shore, MD - (tbs2001@med.cornell.edu) |
| New York University Langone Medical Center New York, New York | A. Samer Al-Homsi, MD - (Samer.Al-Homsi@nyumc.org) Kelli Cole - (Kelli.cole@nyumc.org) |
| Nih/Nhlbi Bethesda, Maryland | Richard Childs, MD - (childsr@nih.gov) |
| Nih/Niaid Bethesda, Maryland | Elizabeth Kang, MD - (ekang@niaid.nih.gov) |
| Niklaus Children's Hospital Miami, Florida | Jorge Galvez-Silva, MD - (jorgericardo.galvezsilva@nicklaushealth.org) |
| North Shore University Hospital Manhasset, New York | Ruthee L Bayer, MD - (rbayer@nshs.edu) |
| Northside Hospital Atlanta, Georgia | Scott Solomon, MD - (ssolomon@bmtga.com) |
| Northwestern Memorial Hospital Chicago, Illinois | Kehinde Adekola, MD - (kehinde-adekola@northwestern.edu) |
| Oregon Health & Science University/Doernbecher Children's Hospital Portland, Oregon | Eneida Nemecek, MD - (nemeceke@ohsu.edu) |
| Orlando Health Bone Marrow Transplant and Cellular Therapy Orlando, Florida | Yasser Khaled, MD - (yasser.khaled@orlandohealth.com) |
| Penn State Milton S. Hershey Cancer Center Hershey, Pennsylvania | Shin Mineishi, MD - (smineishi@pennstatehealth.psu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | |
| Presbyterian St. Luke's/Colorado Blood Cancer Institute Denver, Colorado | Alireza Eghtedar, MD - (alireza.eghtedar@healthonecares.com) |
| Rady Children's Hospital San Diego San Diego, California | Eric Anderson, MD - (eanderson@rchsd.org) |
| Robert Wood Johnson/Cancer Institute of New Jersey New Brunswick, New Jersey | Matthew Matasar, MD, MS - (mm3511@cinj.rutgers.edu) |
| Roger Williams Medical Center Providence, Rhode Island | Todd Roberts, MD - (todd.roberts@chartercare.org) |
| Roswell Park Cancer Institute Buffalo, New York | Philip McCarthy, MD - (philip.mccarthy@roswellpark.org) |
| Rush University Medical Center Chicago, Illinois | |
| Sarah Cannon BMT Program Nashville, Tennessee | |
| Scripps Green Hospital La Jolla, California | Jeffrey W Andrey, MD - (andrey.jeffrey@scrippshealth.org) |
| Southwest Cancer Treatment & Research Center Lubbock, Texas | |
| Spectrum Health Grand Rapids, Michigan | Aly Abdel-Mageed, MD - (aly.mageed@helendevoschildrens.org) |
| St. Jude Childrens Research Hospital Memphis, Tennessee | Renee Madden, MD - (renee.madden@stjude.org) |
| St. Louis University Medical Center St. Louis, Missouri | Sagun Goyal, MD - (sgoyal3@slu.edu) |
| Stanford University Medical Center Palo Alto, California | Andrew Rezvani, MD - (arezvani@stanford.edu) |
| Stony Brook University Hospital Stony Brook, New York | Michael Schuster, MD - (mschuster@notes.cc.sunysb.edu) |
| Strong Memorial Hospital/University of Rochester Rochester, New York | Omar Aljitawi, MD - (omar_aljitawi@urmc.rochester.edu) |
| Sutter Medical Center Sacramento, California | Michael Carroll, MD - (carrolmp@sutterhealth.org) |
| Texas Children's Hospital - Baylor Medical Center Houston, Texas | Robert Krance, MD - (rakrance@txch.org) |
| The Arthur G. James Cancer Hospital/The Ohio State University Medical Center Columbus, Ohio | Sumithira Vasu, MD - (sumithira.vasu@osumc.edu) |
| The Children's Hospital of San Antonio San Antonio, Texas | Martin Andreansky, MD, PhD - (martin.andreansky@bcm.edu) Mark Schambura - (Mark.schambura@christushealth.org) |
| The Jewish Hospital Cincinnati, Ohio | |
| Tufts Medical Center Boston, Massachusetts | Andreas Klein, MD - (aklein2@tuftsmedicalcenter.org) |
| Tulane Medical Center New Orleans, Louisiana | Hana Safa, MD - (hsafah@tulane.edu) |
| UCLA Santa Monica, California | Gary Schiller, MD - (gschiller@mednet.ucla.edu) |
| UCSF (adults) San Francisco, California | |
| UCSF (peds) San Francisco, California | |
| Univeristy of Mississippi Medical Center Jackson, Mississippi | Carolyn Bigelow, MD - (cbigelow@umc.edu) |
| University Hospitals Case Medical Center Cleveland, Ohio | Hillard Lazarus, MD - (hillard.lazarus@case.edu) |
| University of Alabama at Birmingham Birmingham, Alabama | Joseph Chewning, MD - (jchewning@peds.uab.edu) |
| University of Arizona Medical Center - Tucson Tucson, Arizona | Emmanuel Katsanis, MD - (katsanis@peds.arizona.edu) |
| University of California San Diego San Diego, California | Edward Ball, MD - (tball@ucsd.edu) |
| University of Chicago Chicago, Illinois | James LaBelle, MD, PhD - (jlabelle@peds.bsd.uchicago.edu) |
| University of Colorado Hospital Aurora, Colorado | Jonathan Gutman, MD - (jonathan.gutman@ucdenver.edu) |
| University of Florida Shands Medical Center Gainesville, Florida | Jordan Milner, MD - (jordan.milner@ufl.edu) |
| University of Illinois at Chicago Chicago, Illinois | Damiano Rondelli, MD - (drond@uic.edu) |
| University of Iowa Iowa City, Iowa | Margarida Silverman, MD - (margarida-silverman@uiowa.edu) |
| University of Kansas Westwood, Kansas | Joseph McGuirk, DO - (jmcguirk@kumc.edu) |
| University of Louisville Hospital - James Brown Cancer Center Louisville, Kentucky | William Tse, MD - (w0tse002@louisville.edu) |
| University of Massachusetts Worcester, Massachusetts | Jan Cerny, MD - (Jan.Cerny@umassmemorial.org) |
| University of Miami (adult) Miami, Florida | |
| University of Miami (peds) Miami, Florida | |
| University of Michigan Ann Arbor, Michigan | Jessica Yu - (jjxyu@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Phyllis Warkenton, MD - (pwarkent@unmc.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| University of Oklahoma Health Science Center Oklahoma City, Oklahoma | Adam Asch, MD - (adam-asch@ouhsc.edu) |
| University of Pennsylvania/Thomas Jefferson Pittsburg, Pennsylvania | Elizabeth Hexner, MD - (elizabeth.hexner@uphs.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Alison Sehgal, MD - (sehgalar@upmc.edu) |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Utah Salt Lake City, Utah | Ahmad Rayes, MD - (ahmad.rayes@hsc.utah.edu) |
| University of Virginia Charlottesville, Virginia | Karen Ballen, MD - (KB3TC@hscmail.mcc.virginia.edu) |
| University of Wisconsin - Madison Madison, Wisconsin | Kenneth DeSantes, MD - (kbdesantes@pediatrics.wisc.edu) |
| VA Puget Sound HCS Seattle, Washington | |
| VA Tennessee Valley Healthcare System Nashville, Tennessee | |
| Vanderbilt University Nashville, Tennessee | Michael Byrne, MD - (michael.byrne@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | John McCarty, MD - (jmccarty@vcu.edu) |
| Wake Forest University Winston-Salem, North Carolina | |
| Washington University St. Louis St Louis, Missouri | Geoffrey Uy, MD - (guy@wustl.edu) |
| Washington University/St. Louis Children's Hospital St Louis, Missouri | Geoffrey Uy, MD - (guy@wustl.edu) |
| West Virginia University Morgantown, West Virginia | Lauren Veltri, MD - (lveltri@hsc.wvu.edu) |
| Westchester Medical Center Valhalla, New York | Mitchell Cairo, MD - (mitchell_cairo@nymc.edu) |
| Western Penn Hospital Pittsburg, Pennsylvania | John Lister, MD - (Jlister@wpahs.org) |
| Yale New Haven Hospital New Haven, Connecticut | Aaron Flagg, MD - (aron.flagg@yale.edu) |
| Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center) Fort Sam Houston, Texas | Bradley Beeler, MD - (bradley.w.beeler.mil@health.mil) |
Project: Every Child for Younger Patients With Cancer (EVERYCHILD)
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Massey, Gita, V.
NCT02402244
HM20006485
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Inclusion Criteria:
* Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem
* Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority
* Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
* All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one "1" (borderline), two "2" (carcinoma in situ) or three "3" (malignant)
* All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
* All neoplastic lesions of the kidney regardless of behavior, i.e., benign, borderline or malignant
* The following other benign/borderline conditions:
* Mesoblastic nephroma
* Teratomas (mature and immature types)
* Myeloproliferative diseases including transient myeloproliferative disease
* Langerhans cell histiocytosis
* Lymphoproliferative diseases
* Desmoid tumors
* Gonadal stromal cell tumors
* Neuroendocrine tumors including pheochromocytoma
* Melanocytic tumors, except clearly benign nevi
* Ganglioneuromas
* Subjects must be =\< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network \[NCTN\]) therapeutic study, for which there is a higher upper age limit
* All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission
* If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1 OTHER: Cytology Specimen Collection Procedure, OTHER: Medical Chart Review
Adrenal Gland Pheochromocytoma, Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Kidney Neoplasm, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid Fibromatosis, Ganglioneuroma, Lymphoproliferative Disorder, Malignant Neoplasm, Malignant Solid Neoplasm, Melanocytic Neoplasm, Myeloproliferative Neoplasm, Neoplasm of Uncertain Malignant Potential, Neuroendocrine Neoplasm, Stromal Neoplasm
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Show 274 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Brooke Army Medical Center Fort Sam Houston, Texas | |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Drexel University School of Medicine Philadelphia, Pennsylvania | |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| Hurley Medical Center Flint, Michigan | |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| King Faisal Specialist Hospital and Research Centre Riyadh, | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pebble Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pecos Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | Site Public Contact - (research@smcrf.org) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Monash Medical Center-Clayton Campus Clayton, Victoria | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Naval Medical Center -San Diego San Diego, California | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Northwestern Medicine Central DuPage Hospital Winfield, Illinois | Site Public Contact - (Claudine.Gamster@CadenceHealth.org) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oncology Las Vegas - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Palms West Radiation Therapy Loxahatchee Groves, Florida | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Princess Margaret Hospital for Children Perth, Western Australia | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Royal Children's Hospital Parkville, Victoria | |
| Royal Hobart Hospital Hobart, | |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint John's Hospital Springfield, Illinois | Site Public Contact - (diana.weyhenmeyer@st-johns.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| San Jorge Children's Hospital San Juan, | |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Saskatoon Cancer Centre Saskatoon, Saskatchewan | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Starship Children's Hospital Grafton, Auckland | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sydney Children's Hospital Randwick, New South Wales | |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Tripler Army Medical Center Honolulu, Hawaii | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vannie Cook Children's Clinic McAllen, Texas | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | |
| Wesley Medical Center Wichita, Kansas | Site Public Contact - (WesleyResearch@wesleymc.com) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Women's and Children's Hospital-Adelaide North Adelaide, South Australia | Site Public Contact - (cywhs.oncsec@health.sa.gov.au) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Massey, Gita, V.
NCT00904241
HM1538
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Inclusion Criteria:
* All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study
* There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype
* Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and procurement of study-related tissues with the following exception:
* Patients that in the opinion of the treating physician are too ill to undergo pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on ANBL00B1; documentation of the emergent nature of therapy initiation is required
* It is required that a good faith effort (documented by specimen tracking) be made to submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow) of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be obtained prior to initiation of therapy
* Exceptions
* In rare cases, patients may be deemed too ill to undergo pre-treatment tissue biopsy and require EMERGENT therapy; the following eligibility guidelines apply to these cases:
* For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g., primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT therapy initiation should be made; however, if the child is deemed too unstable for such a procedure they may still be enrolled as long as pre-treatment peripheral blood and serum have been submitted
* For all other INSS stages: tumor tissue should be obtained as soon as possible within 96 hours of EMERGENT therapy initiation; patients without tumor tissues submitted within this time-frame are not eligible for enrollment
* Note: it may not be possible to obtain all necessary tumor biomarkers for therapy stratification in such cases; if a patient enrolled on ANBL00B1 undergoes an additional diagnostic procedure within 96 hours of initiating therapy, additional tumor specimens may be submitted to obtain biomarkers used for risk classification; the decision to perform such procedures, and/or submit these specimens, is to be made by the managing clinicians and should reflect the clinical need to know the status of such biomarkers
* Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a tumor biopsy or resection upfront; tumor tissue submission is therefore not required for these patients to enroll on ANBL00B1; a peripheral blood and serum sample is the only specimen required to be submitted for this group of patients; should they undergo a biopsy or resection at a later date tumor can be submitted for biomarker testing at this time
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol OTHER: Cytology Specimen Collection Procedure, OTHER: Laboratory Biomarker Analysis
Ganglioneuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma
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Show 259 locations
Study Locations
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| Location | Contacts |
|---|---|
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (dperry@nemours.org) |
| Allan Blair Cancer Centre Regina, Saskatchewan | |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (melissa.leffin@orlandohealth.com) |
| Ascension Saint John Hospital Detroit, Michigan | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beaumont Children's Hospital-Royal Oak Royal Oak, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Brooke Army Medical Center Fort Sam Houston, Texas | |
| Brooklyn Hospital Center Brooklyn, New York | |
| Broward Health Medical Center Fort Lauderdale, Florida | |
| C S Mott Children's Hospital Ann Arbor, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Cardon Children's Medical Center Mesa, Arizona | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Carilion Clinic Children's Hospital Roanoke, Virginia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | |
| Centre Hospitalier Universitaire de Quebec Québec, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Healthcare of Atlanta - Egleston Atlanta, Georgia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital London, Ontario | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Los Angeles Los Angeles, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Medical Center Of Akron Akron, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital New Orleans New Orleans, Louisiana | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital and Research Center at Oakland Oakland, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Columbia Regional Columbia, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Dayton Children's Hospital Dayton, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| East Tennessee State University Johnson City, Tennessee | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Eastern Maine Medical Center Bangor, Maine | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Floating Hospital for Children at Tufts Medical Center Boston, Massachusetts | |
| Florida Hospital Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Greenville Cancer Treatment Center Greenville, South Carolina | |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Henry Ford Hospital Detroit, Michigan | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (jason.mcguire@sickkids.ca) |
| Hurley Medical Center Flint, Michigan | |
| IWK Health Centre Halifax, Nova Scotia | |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente Washington Seattle, Washington | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kalamazoo Center for Medical Studies Kalamazoo, Michigan | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| King Faisal Specialist Hospital and Research Centre Riyadh, | |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (prmc.coordinator@nyumc.org) |
| Lee Memorial Health System Fort Myers, Florida | |
| Legacy Emanuel Children's Hospital Portland, Oregon | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Legacy Emanuel Hospital and Health Center Portland, Oregon | |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Torrance, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| M D Anderson Cancer Center Houston, Texas | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (mamcdci@amedd.army.mil) |
| Maimonides Medical Center Brooklyn, New York | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Mayo Clinic Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (clayter1@memorialhealth.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Children's Hospital Toledo, Ohio | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Miami Cancer Institute Miami, Florida | Site Public Contact - (cancerinfo@baptisthealth.net) |
| Michigan State University Clinical Center East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Mission Hospital Inc-Memorial Campus Asheville, North Carolina | Site Public Contact - (leslie.verner@msj.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (nr2616@cumc.columbia.edu) |
| NYU Winthrop Hospital Mineola, New York | |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Naval Medical Center -San Diego San Diego, California | |
| Nemours Children's Clinic - Orlando Orlando, Florida | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | |
| Nicklaus Children's Hospital Miami, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (nnechiporchik@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Gregory.Johnstone@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Overlook Hospital Summit, New Jersey | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Primary Children's Hospital Salt Lake City, Utah | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Princess Margaret Hospital for Children Perth, Western Australia | |
| Prisma Health Richland Hospital Columbia, South Carolina | |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Queensland Children's Hospital South Brisbane, Queensland | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rady Children's Hospital - San Diego San Diego, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Royal Brisbane and Women's Hospital Herston, Queensland | |
| Royal Children's Hospital Parkville, Victoria | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Royal Children's Hospital-Brisbane Herston, Queensland | |
| Rush University Medical Center Chicago, Illinois | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Barnabas Medical Center Livingston, New Jersey | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Mountain States Tumor Institute Boise, Idaho | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Mary's Hospital Rhinelander, Wisconsin | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (Christy.Gilchrist@hshs.org) |
| Saint Vincent Hospital and Health Care Center Indianapolis, Indiana | |
| San Jorge Children's Hospital San Juan, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Saskatoon Cancer Centre Saskatoon, Saskatchewan | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Sinai Hospital of Baltimore Baltimore, Maryland | Site Public Contact - (pridgely@lifebridgehealth.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| St. Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Starship Children's Hospital Grafton, Auckland | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| State University of New York Downstate Medical Center Brooklyn, New York | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (cancerinfo@sutterhealth.org) |
| Swiss Pediatric Oncology Group - Bern Bern, | |
| Swiss Pediatric Oncology Group - Geneva Geneva, | |
| Swiss Pediatric Oncology Group - Lausanne Lausanne, | |
| Sydney Children's Hospital Randwick, New South Wales | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| T C Thompson Children's Hospital Chattanooga, Tennessee | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| The Children's Hospital at Westmead Westmead, New South Wales | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio | |
| The University of Arizona Medical Center-University Campus Tucson, Arizona | |
| Tod Children's Hospital - Forum Health Youngstown, Ohio | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Tripler Army Medical Center Honolulu, Hawaii | |
| Tulane University Health Sciences Center New Orleans, Louisiana | |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | |
| UCSF Medical Center-Parnassus San Francisco, California | |
| UF Cancer Center at Orlando Health Orlando, Florida | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center Groningen Groningen, | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University Pediatric Hospital San Juan, | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (val.taylor@albertahealthservices.ca) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Massachusetts Medical School Worcester, Massachusetts | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (LByatt@nmcca.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Texas Medical Branch Galveston, Texas | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (PAS9E@virginia.edu) |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | |
| Valley Children's Hospital Madera, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (mwellons@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| William Beaumont Hospital-Royal Oak Royal Oak, Michigan | |
| Women's and Children's Hospital-Adelaide North Adelaide, South Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Longitudinal Observational Study of the Natural History and Management of Patients With HCC
Stephanie Harrison - sharrison@targetrwe.com
Lee, Hannah, M.
NCT02954094
HM20011686
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Inclusion Criteria:
• Male or female patients, age ≥18 years
• Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)
Exclusion Criteria:
1\. Inability to provide written informed consent Hepatocellular Cancer
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Show 72 locations
Study Locations
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| Location | Contacts |
|---|---|
| A.O.U.P. di Palermo Palermo, | |
| Banner University Medical Center Phoenix, Arizona | |
| Baylor Scott & White All Saints Fort Worth, Texas | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Bon Secours Liver Institute of Virginia Richmond, Virginia | |
| CHU de Nice - Hôpital L'Archet 2 Nice, | |
| California Liver Research Institute Pasadena, California | |
| Center for Liver Disease and Transplant at CMC Charlotte, North Carolina | |
| Charite - Universitatsmedizin Berlin Berlin, | |
| Clinica Universidad de Navarra Madrid, | |
| Clinical Research Institute@ Methodist Dallas Medical Center Dallas, Texas | |
| Columbia University New York, New York | |
| Complejo Hospitalario Universitario A Coruna A Coruña, | |
| Emory University Hospital Atlanta, Georgia | |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, | |
| Gastro Florida Clearwater, Florida | |
| Georgetown University Washington D.C., District of Columbia | |
| Harborview Medical Center Seattle, Washington | |
| Henry Ford Health System Jackson, Michigan | |
| Hospital Puerta de Hierro Majadahonda Madrid, | |
| Hospital Universitario Marqués de Valdecilla Santander, | |
| Hospital Universitario Politècnic La Fe Valencia, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Humanitas Mirasole IRCCS Rozzano, | |
| Hôpitaux Universitaires Paris Centre Paris, | |
| IRCCS "Casa Sollievo della Sofferenza" San Giovanni Rotondo, | |
| Johns Hopkins University Baltimore, Maryland | |
| Mayo Clinic Rochester, Minnesota | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medizinische Hochschule hannover Hanover, | |
| Mercy Medical Center, GI Research Baltimore, Maryland | |
| NYU Langone Health New York, New York | |
| Northwell Health - Center for Liver Diseases Manhasset, New York | |
| Northwestern University Division of Gastroenterology and Hepatology Chicago, Illinois | |
| Penn State Hershey Medical Center Hershey, Pennsylvania | |
| Piedmont Atlanta Hospital Atlanta, Georgia | |
| Piedmont Cancer Institute Atlanta, Georgia | |
| Providence Health & Services Cancer Clinical Trials Portland, Oregon | |
| Research Specialists of Texas Houston, Texas | |
| Rush University Medical Center Chicago, Illinois | |
| Rutgers-Robert Wood Johnson Medical School New Brunswick, New Jersey | |
| Saint Louis University St Louis, Missouri | |
| Schiff Center for Liver Diseases/University of Miami Miami, Florida | |
| Southern Therapy and Advanced Research (STAR) LLC Jackson, Mississippi | |
| Stanford University Palo Alto, California | |
| Tampa General Medical Group Tampa, Florida | |
| Tulane University New Orleans, Louisiana | |
| Universitatsklinikum Leipzig Leipzig, Saxony | |
| Universitatsmedizin Mainz Mainz, | |
| University of Arkansas Little Rock, Arkansas | |
| University of California San Francisco, California | |
| University of California-Davis Sacramento, California | |
| University of Chicago Chicago, Illinois | |
| University of Florida Health Gastroenterology Jacksonville, Florida | |
| University of Florida Hepatology Research at CTRB Gainesville, Florida | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| University of Michigan Ann Arbor, Michigan | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Southern California/Norris Comprehensive Cancer Center Los Angeles, California | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Virginia Charlottesville, Virginia | |
| University of Wisconsin Madison, Wisconsin | |
| Universitätsklinikum Aachen Aachen, | |
| Universitätsklinikum Düsseldorf Düsseldorf, | |
| Universitätsklinikum Frankfurt Frankfurt, | |
| Universitätsklinikum Magdeburg Magdeburg, | |
| Vanderbilt University Medical Center - GI Research Office Nashville, Tennessee | |
| Virginia Commonwealth University Richmond, Virginia | |
| Weill Cornell Medical College New York, New York | |
| Wenatchee Valley Hospital & Clinics Wenatchee, Washington |
Neuroblastoma Maintenance Therapy Trial (NMTT)
BCC Enroll - BCCEnroll@pennstatehealth.psu.edu
Gowda, Madhu, S
NCT02679144
HM20015342
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Inclusion Criteria:
* All patients must have a pathologically confirmed diagnosis of neuroblastoma, \< 30.99 years of age and classified as high risk at the time of diagnosis. Exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible.
* All patients must be in complete remission (CR):
• No evidence of residual disease on scan
• No evidence of disease metastatic to bone marrow. * Specific Criteria by Stratum: Stratum 1/1B: All patients must have completed standard upfront therapy that replicates treatment which patients who were enrolled on ANBL0032 received, including: intensive induction chemotherapy and (if feasible) resection of primary tumor, followed by: consolidation with high-dose chemotherapy with stem cell transplant and radiotherapy, followed by: immunotherapy with Ch14.18/IL-2/GM-CSF (dinutuximab) and retinoic acid;. All subjects on Stratum 1/B must have also met the following criteria: • A pre-transplant disease status evaluation that met International Neuroblastoma Response Criteria (INRC) for CR (complete response), VGPR (very good partial response), or PR (partial response) for primary site, soft tissue metastases and bone metastases. Patients who meet those criteria must also meet the protocol-specified criteria for bone marrow response prior to transplant as outlined below: No more than 10% tumor involvement (based on total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy. Stratum 2: Neuroblastoma that is in first complete remission following standard upfront therapy different from that described for Stratum 1. Stratum 3: Neuroblastoma that failed to have a response of at least PR following induction chemotherapy and surgical resection of the primary tumor, but that has achieved CR following additional therapy. Stratum 4: Patients who have achieved a second or subsequent CR following relapse(s). * Pre-enrollment tumor survey: Prior to enrollment on this study, a determination of mandatory disease staging must be performed: * Tumor imaging studies including * Bilateral bone marrow aspirates and biopsy * This disease assessment is required for eligibility and preferably should be done within 2 weeks prior to enrollment, but must be done within a maximum of 4 weeks before enrollment. * Timing from prior therapy: Stratum 1/1B: Enrollment no later than 60 days after completion of upfront therapy, (last dose of cis-retinoic acid) with a maximum of 6 cycles of cis-retinoic acid maintenance therapy. Stratum 2, 3 and 4: Enrollment no later than 60 days from last dose of the most recent therapy. * Patients must have a Lansky or Karnofsky Performance Scale score of \> 50% and patients must have a life expectancy of ≥ 2 months. * All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated below. * Patients must have adequate organ functions at the time of registration: * Hematological: Total absolute phagocyte count ≥1000/μL * Liver: Subjects must have adequate liver function * Renal: Adequate renal function * Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding. * Written informed consent in accordance with institutional and FDA (food and drug administration) guidelines must be obtained from all subjects (or patients' legal representative).
Exclusion Criteria:
* BSA (Body Surface Area) of \<0.25 m2.
* Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
* Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from hematological and bone marrow suppression effects of prior chemotherapy.
* Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
* Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded. DRUG: Difluoromethylornithine (DFMO)
Neuroblastoma
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Show 47 locations
Study Locations
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| Location | Contacts |
|---|---|
| Alberta Children's Hospital Calgary, Alberta | Sherry Qian - (Sherry.Qian@albertahealthservices.ca) |
| All Children's Hospital Johns Hopkins Medicine St. Petersburg, Florida | Emily Riffle - (eriffle2@jhmi.edu) |
| Arkansas Children's Hospital Little Rock, Arkansas | Susan Hall - (HallSF@archildrens.org) |
| Arnold Palmer Hospital for Children Orlando, Florida | Michelle Pellet - (Michelle.Pellett@orlandohealth.com) |
| Augusta University Health Augusta, Georgia | Kimberly Gray - (kigray@augusta.edu) |
| CHUQ Québec, Quebec | Valérie-Ève Julien - (Valerie-Eve.Julien@crchudequebec.ulaval.ca) |
| CIUSSS de l'Estrie-CHUS Sherbrooke, Quebec | Cassandra Leblanc Desrochers - (cassandra.leblanc-desrochers.ciussse-chus@ssss.gouv.qc.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Krista Mueller - (kmueller@cancercare.mb.ca) |
| Children's Hospital and Clinics of Minnesota Minneapolis, Minnesota | Nel Siemsen - (Nel.Siemsen@childrensmn.org) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Sabrina Wigginton - (Sabrina.Wigginton@chkd.org) |
| Children's Medical Center Dallas, Texas | Michelle Rivas - (michelle.rivas@childrens.com) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Nicole Harvey - (ndharvey@cmh.edu) |
| Cleveland Clinic Children's Cleveland, Ohio | Luba Platt - (PLATTL@ccf.org) |
| Connecticut Children's Hospital Hartford, Connecticut | Nicole McCracken - (NMccracken@connecticutchildrens.org) |
| Dell Children's Blood and Cancer Center Austin, Texas | Rhea Robinson, RN - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Duke University Durham, North Carolina | Diana Sedito - (diana.sedito@duke.edu) |
| Gina Martin St Louis, Missouri | Gina Martin, RN - (gina.martin@health.slu.edu) |
| Hackensack University Medical Center Hackensack, New Jersey | Sherri Mayans - (sherri.mayans@hmhn.org) |
| Hasbro Children's Hospital Providence, Rhode Island | Christopher Bouressa - (cbouressa@lifespan.org) |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | Mary Beth Readwin - (mary.readwin2@corewellhealth.org) |
| Janesway Children's Health and Rehabilitation Centre St. John's, Newfoundland and Labrador | Bev Mitchell - (Beverlyj.mitchell@easternhealth.ca) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | Andrea Siu, MPH - (andrea.siu@kapiolani.org) |
| Kentucky Children's Hospital Lexington, Kentucky | Tammy Taylor - (ttayl2@email.uky.edu) |
| Levine Children's Hospital Charlotte, North Carolina | Jotnyce Green - (jontyce.green@atriumhealth.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | Ashley Hain - (ahain@childrenswi.org) |
| Medical University of South Carolina Charleston, South Carolina | Shanta Salzar, MD - (salzers@musc.edu) |
| Monroe Carrell Jr. Children's Hospital at Vanderbilt Nashville, Tennessee | Aida Constantinescu - (aida.constantinescu@vumc.org) |
| Montreal Children's Hospital Montreal, Quebec | Dominique Lafreniere - (Dominique.Lafreniere@MUHC.MCGILL.CA) |
| Nationwide Children's Hospital Columbus, Ohio | |
| New York University New York, New York | Anna Yaffe - (Anna.Yaffe@nyumc.org) |
| Penn State Milton S. Hershey Medical Center and Children's Hospital Hershey, Pennsylvania | Suzanne Treadway - (streadway@hmc.psu.edu) |
| Primary Children's Hospital Salt Lake City, Utah | Group Contact - (Pc-cog@imail.org) |
| Rady Children's Hospital San Diego, California | Franchesca Ramirez - (framirez@rchsd.org) |
| Randall Children's Hospital Portland, Oregon | Aaron White - (AJWHITE@lhs.org) |
| Rebecca McFall Chicago, Illinois | Jennifer Ward, MD - (jennifer.ward@aah.org) |
| Rocky Mountain Pediatric Hematology Denver, Colorado | Marlie Mounts - (Marlie.Mounts@HealthONEcares.com) |
| St. Joseph's Children's Hospital Tampa, Florida | Jennifer Manns, RN - (jennifer.manns@baycare.org) |
| St. Lukes Boise, Idaho | Callie Wiskus - (wiskusca@slhs.org) |
| Texas Children's Cancer and Hematology Centers Houston, Texas | Cara-Lee Fontaine - (clfontai@texaschildrens.org) |
| Tufts Medical Center Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland- Oakland, California | Group Contact - (PedOncRschOAK@ucsf.edu) |
| UHC Sainte-Justine Montreal, Quebec | Guillaume Leblanc - (guillaume.leblanc.hsj@ssss.gouv.qc.ca) |
| University of Alabama, Children's of Alabama Birmingham, Alabama | Bridget Tate - (btate@peds.uab.edu) |
| University of Florida Gainesville, Florida | Ashley Bayne - (abayne@UFL.EDU) |
| University of Louisville Louisville, Kentucky | Jennifer Miller - (Jennifer.Miller4@nortonhealthcare.org) |
| University of Massachusetts Medical School Worcester Worcester, Massachusetts | |
| Virginia Commonwealth University Richmond, Virginia | Mary Madu - (memadu@vcu.edu) |
Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma (Mel-65)
Samantha Schaeffer - SMS6WN@uvahealth.org
Poklepovic, Andrew, S
NCT03617328
HM20019005
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Main
• Patients with stage IIB, IIC, III, or IV melanoma at original diagnosis or at restaging after recurrence, rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
• Patients with small radiologic or clinical findings of an indeterminate nature may be eligible.
• Patients with high-risk stage IIA melanoma (by DecisionDx Melanoma test, Castle Biosciences, Inc., Friendswood, TX) may be eligible.
• Participants may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma. Diagnosis of melanoma must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on version 8 AJCC staging system.
• Participants who have had brain metastases will be eligible if all of the following are true:
• Each brain metastasis must have been completely removed by surgery or each unresected brain metastasis must have been treated with stereotactic radiosurgery.
• No brain metastasis is > 2 cm in diameter at the time of registration.
• Any neurologic symptoms attributable to brain metastases have returned to baseline.There is no evidence of new or enlarging brain metastases.
• The most recent surgical resections or gamma-knife therapy for malignant melanoma must have been completed ≥ 1 week and ≤ 6 months prior to registration.
• ECOG performance status of 0 or 1.
• Ability and willingness to give informed consent.
• Adequate organ function
• Age 18 years or older at registration. Main
• The following medications or treatments at any time within 4 weeks of registration:
• Chemotherapy
• Interferon (e.g. Intron-A®)
• Radiation therapy (Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week and ≤ 6 months prior to registration)
• Allergy desensitization injections
• High doses of systemic corticosteroids
• Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
• Interleukins (e.g. Proleukin®)
• Any investigational medication
• Targeted therapies specific for mutated BRAF or for MEK
• Nitrosoureas within 6 weeks of registration.
• Checkpoint molecule blockade therapy within 12 weeks of registration.
• Known or suspected allergies to any component of the vaccine.
• Previous vaccination with 6MHP.
• Prior treatment with CDX-1127 or other CD27 agonistic antibody.
• Pregnancy.
• HIV positivity or evidence of active Hepatitis C virus.
• Female participants must not be breastfeeding.
• A medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
• New York Heart Association classification as having Class III or IV heart disease.
• Uncontrolled diabetes, defined as having an HgbA1c > 8.5%.
• Prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded.
• Participants with known addiction to alcohol or drugs who are actively taking those agents, or participants with recent (within 1 year) or ongoing illicit IV drug use.
• Participants who have received a live vaccine within 30 days of registration.
• Body weight < 110 pounds at registration, due to the amount and frequency with which blood will be drawn.
• Participants with prior autoimmune pneumonitis.
Inclusion Criteria:
• Patients with stage IIB, IIC, III, or IV melanoma at original diagnosis or at restaging after recurrence, rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
• Patients with small radiologic or clinical findings of an indeterminate nature may be eligible.
• Patients with high-risk stage IIA melanoma (by DecisionDx Melanoma test, Castle Biosciences, Inc., Friendswood, TX) may be eligible.
• Participants may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma. Diagnosis of melanoma must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on version 8 AJCC staging system.
• Participants who have had brain metastases will be eligible if all of the following are true:
• Each brain metastasis must have been completely removed by surgery or each unresected brain metastasis must have been treated with stereotactic radiosurgery.
• No brain metastasis is > 2 cm in diameter at the time of registration.
• Any neurologic symptoms attributable to brain metastases have returned to baseline.There is no evidence of new or enlarging brain metastases.
• The most recent surgical resections or gamma-knife therapy for malignant melanoma must have been completed ≥ 1 week and ≤ 6 months prior to registration.
• ECOG performance status of 0 or 1.
• Ability and willingness to give informed consent.
• Adequate organ function
• Age 18 years or older at registration. Main
Exclusion Criteria:
• The following medications or treatments at any time within 4 weeks of registration:
• Chemotherapy
• Interferon (e.g. Intron-A®)
• Radiation therapy (Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week and ≤ 6 months prior to registration)
• Allergy desensitization injections
• High doses of systemic corticosteroids
• Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
• Interleukins (e.g. Proleukin®)
• Any investigational medication
• Targeted therapies specific for mutated BRAF or for MEK
• Nitrosoureas within 6 weeks of registration.
• Checkpoint molecule blockade therapy within 12 weeks of registration.
• Known or suspected allergies to any component of the vaccine.
• Previous vaccination with 6MHP.
• Prior treatment with CDX-1127 or other CD27 agonistic antibody.
• Pregnancy.
• HIV positivity or evidence of active Hepatitis C virus.
• Female participants must not be breastfeeding.
• A medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
• New York Heart Association classification as having Class III or IV heart disease.
• Uncontrolled diabetes, defined as having an HgbA1c > 8.5%.
• Prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded.
• Participants with known addiction to alcohol or drugs who are actively taking those agents, or participants with recent (within 1 year) or ongoing illicit IV drug use.
• Participants who have received a live vaccine within 30 days of registration.
• Body weight < 110 pounds at registration, due to the amount and frequency with which blood will be drawn.
• Participants with prior autoimmune pneumonitis.
Biological: 6MHP, Drug: Montanide ISA-51, Drug: polyICLC, Drug: CDX-1127
Melanoma
peptide, vaccine, adjuvant, 6MHP, polyICLC, varlilumab, CDX-1127, Montanide ISA-51
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Study Locations
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| Location | Contacts |
|---|---|
| University of Virginia Charlottesville, Virginia | Samantha Schaeffer - (SMS6WN@uvahealth.org) |
| Virginia Commonwealth University Richmond, Virginia | Faith McFadden, RN, BSN - (mcfaddenfr@vcu.edu) Carrie Donovan, RN - (donovan2@vcu.edu) |
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors (A5481092)
Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com
Austin, Frances
NCT03709680
HM20017464
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Inclusion:
• Histologically confirmed relapsed or refractory solid tumor as follows:
• For dose escalation and dose determination parts: Histologically confirmed relapsed or refractory solid tumor (including CNS tumors but not lymphomas). Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll.
• For dose expansion and tumor specific cohorts: Histologically confirmed relapsed or refractory solid tumor including but not limited to EWS, rhabdoid tumor, rhabdomyosarcoma, neuroblastoma, and medulloblastoma. Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll. EWS is not eligible for TOPO and CTX tumor-specific cohorts.
• For randomized Phase 2 part: Histologically confirmed Ewing sarcoma at diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS rearrangement. Histopathology confirmation of both EWSR1-ETS or FUS-ETS rearrangement partners is required OR availability of formalin fixed paraffin embedded (FFPE) tumor tissue sample for central testing. Patient must have relapsed or have refractory disease and at least evaluable disease in at least one site other than bone marrow that can be followed by imaging.
• Age ≥2 and <21 years at the time of study entry.
• Lansky performance status ≥50% for patients ≤16 years of age, or Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 for patients >16 years of age.
• Adequate bone marrow function.
• Absolute neutrophil count ≥1000/mm3;
• Platelet count ≥100,000/mm3 (transfusion independent, no platelet transfusion in past 7 days prior study entry);
• Hemoglobin ≥8.5 g/dL (transfusion allowed).
• Adequate renal function: Serum creatinine level based on age/gender must within protocol specified limits.
• Adequate liver function, including:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) or ≤5 × ULN for age, if attributable to disease involvement of the liver;
• Total bilirubin ≤1.5 × ULN for age, unless the patient has documented Gilbert's syndrome.
• Patients enrolled to Phase 1 portion of the study and tumor specific cohorts must have measurable disease as defined by RECIST version 1.1 or modified RANO criteria for CNS disease or INRC for neuroblastoma. Patients with EWS enrolled to Phase 2 portion of the study are eligible with evaluable disease (eg, bone only disease with no soft tissue component).
• Recovered to CTCAE Grade ≤1, or to baseline, from any non-hematological acute toxicities of prior surgery, chemotherapy, immunotherapy, radiotherapy, differentiation therapy or biologic therapy, with the exception of alopecia.
• Serum/urine pregnancy test (for all girls ≥8 years of age) negative at screening and at the baseline visit. Exclusion:
• Phase 1 and tumor specific cohorts: For palbociclib with IRN and TMZ combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing regimen that includes TMZ. Patients who have received the combination of IRN and TMZ and did not progress while on these medications are eligible. For patients enrolling in the palbociclib with TOPO and CTX combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with a TOPO-containing regimen that includes CTX. Patients who have received the combination of TOPO and CTX and did not progress while on these medications are eligible. Phase 2 portion: prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing or TMZ-containing regimen. Patients who have received IRN and/or TMZ and did not progress while on these medications are eligible.
• Prior intolerability to IRN and/or TMZ plus/minus palbociclib with IRN and TMZ combination and prior intolerability to TOPO and/or CTX for TOPO and CTX combination.
• Use of strong cytochrome P450 (CYP) 3A inhibitors or inducers. Patients who are receiving strong uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) inhibitors within 12 days of Cycle 1 Day 1 (C1D1) are not eligible for the palbociclib with IRN and TMZ combination. Patients who are receiving strong UGT1A1 inhibitors within 12 days of C1D1 are eligible for the palbociclib with TOPO and CTX combination (See Section 5.7.1 for list of products.)
• Systemic anti cancer therapy within 2 weeks prior to study entry and 6 weeks for nitrosoureas.
• Prior irradiation to >50% of the bone marrow (see Appendix 9).
• Participation in other studies involving investigational drug(s) within 2 weeks or 5 half lives, whichever is longer, prior to study entry.
• Major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries.
• For IRN and TMZ with/without palbociclib combinations: known or suspected hypersensitivity to palbociclib, IRN and/or TMZ. For combination of palbociclib with TOPO and CTX: known or suspected hypersensitivity to palbociclib, TOPO and/or CTX.
• Patients with known symptomatic brain tumors or brain metastases and require steroids, unless they have been on a stable or on a decreasing steroid dose for >14 days.
• Patients with previously diagnosed brain metastases are eligible if they have completed their prior treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry for these metastases for at least 14 days post radiation and 4 weeks post-surgery and are neurologically stable.
• Hereditary bone marrow failure disorder.
• QTc >470 msec.
• History of clinically significant or uncontrolled cardiac disease, including:
• History of or active congestive heart failure; if patient had congestive heart failure resolve and >1 year from resolution, patient will be considered eligible;
• Clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation or Torsades de Pointes);
• Diagnosed or suspected congenital or acquired prolonged QT syndrome;
• Need for medications known to prolong the QT interval;
• Uncorrected hypomagnesemia or hypokalemia because of potential effects on the QT interval;
• Left ventricular ejection fraction <50% or shortening fraction <28%.
• Recent or ongoing clinically significant gastrointestinal disorder that may interfere with absorption of orally administered drugs (eg, gastrectomy).
• Severe acute or chronic medical or laboratory test abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
• Histologically confirmed relapsed or refractory solid tumor as follows:
• For dose escalation and dose determination parts: Histologically confirmed relapsed or refractory solid tumor (including CNS tumors but not lymphomas). Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll.
• For dose expansion and tumor specific cohorts: Histologically confirmed relapsed or refractory solid tumor including but not limited to EWS, rhabdoid tumor, rhabdomyosarcoma, neuroblastoma, and medulloblastoma. Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll. EWS is not eligible for TOPO and CTX tumor-specific cohorts.
• For randomized Phase 2 part: Histologically confirmed Ewing sarcoma at diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS rearrangement. Histopathology confirmation of both EWSR1-ETS or FUS-ETS rearrangement partners is required OR availability of formalin fixed paraffin embedded (FFPE) tumor tissue sample for central testing. Patient must have relapsed or have refractory disease and at least evaluable disease in at least one site other than bone marrow that can be followed by imaging.
• Age ≥2 and <21 years at the time of study entry.
• Lansky performance status ≥50% for patients ≤16 years of age, or Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 for patients >16 years of age.
• Adequate bone marrow function.
• Absolute neutrophil count ≥1000/mm3;
• Platelet count ≥100,000/mm3 (transfusion independent, no platelet transfusion in past 7 days prior study entry);
• Hemoglobin ≥8.5 g/dL (transfusion allowed).
• Adequate renal function: Serum creatinine level based on age/gender must within protocol specified limits.
• Adequate liver function, including:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) or ≤5 × ULN for age, if attributable to disease involvement of the liver;
• Total bilirubin ≤1.5 × ULN for age, unless the patient has documented Gilbert's syndrome.
• Patients enrolled to Phase 1 portion of the study and tumor specific cohorts must have measurable disease as defined by RECIST version 1.1 or modified RANO criteria for CNS disease or INRC for neuroblastoma. Patients with EWS enrolled to Phase 2 portion of the study are eligible with evaluable disease (eg, bone only disease with no soft tissue component).
• Recovered to CTCAE Grade ≤1, or to baseline, from any non-hematological acute toxicities of prior surgery, chemotherapy, immunotherapy, radiotherapy, differentiation therapy or biologic therapy, with the exception of alopecia.
• Serum/urine pregnancy test (for all girls ≥8 years of age) negative at screening and at the baseline visit. Exclusion:
• Phase 1 and tumor specific cohorts: For palbociclib with IRN and TMZ combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing regimen that includes TMZ. Patients who have received the combination of IRN and TMZ and did not progress while on these medications are eligible. For patients enrolling in the palbociclib with TOPO and CTX combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with a TOPO-containing regimen that includes CTX. Patients who have received the combination of TOPO and CTX and did not progress while on these medications are eligible. Phase 2 portion: prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing or TMZ-containing regimen. Patients who have received IRN and/or TMZ and did not progress while on these medications are eligible.
• Prior intolerability to IRN and/or TMZ plus/minus palbociclib with IRN and TMZ combination and prior intolerability to TOPO and/or CTX for TOPO and CTX combination.
• Use of strong cytochrome P450 (CYP) 3A inhibitors or inducers. Patients who are receiving strong uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) inhibitors within 12 days of Cycle 1 Day 1 (C1D1) are not eligible for the palbociclib with IRN and TMZ combination. Patients who are receiving strong UGT1A1 inhibitors within 12 days of C1D1 are eligible for the palbociclib with TOPO and CTX combination (See Section 5.7.1 for list of products.)
• Systemic anti cancer therapy within 2 weeks prior to study entry and 6 weeks for nitrosoureas.
• Prior irradiation to >50% of the bone marrow (see Appendix 9).
• Participation in other studies involving investigational drug(s) within 2 weeks or 5 half lives, whichever is longer, prior to study entry.
• Major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries.
• For IRN and TMZ with/without palbociclib combinations: known or suspected hypersensitivity to palbociclib, IRN and/or TMZ. For combination of palbociclib with TOPO and CTX: known or suspected hypersensitivity to palbociclib, TOPO and/or CTX.
• Patients with known symptomatic brain tumors or brain metastases and require steroids, unless they have been on a stable or on a decreasing steroid dose for >14 days.
• Patients with previously diagnosed brain metastases are eligible if they have completed their prior treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry for these metastases for at least 14 days post radiation and 4 weeks post-surgery and are neurologically stable.
• Hereditary bone marrow failure disorder.
• QTc >470 msec.
• History of clinically significant or uncontrolled cardiac disease, including:
• History of or active congestive heart failure; if patient had congestive heart failure resolve and >1 year from resolution, patient will be considered eligible;
• Clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation or Torsades de Pointes);
• Diagnosed or suspected congenital or acquired prolonged QT syndrome;
• Need for medications known to prolong the QT interval;
• Uncorrected hypomagnesemia or hypokalemia because of potential effects on the QT interval;
• Left ventricular ejection fraction <50% or shortening fraction <28%.
• Recent or ongoing clinically significant gastrointestinal disorder that may interfere with absorption of orally administered drugs (eg, gastrectomy).
• Severe acute or chronic medical or laboratory test abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Drug: Palbociclib, Drug: Temozolomide, Drug: Irinotecan, Drug: Topotecan, Drug: Cyclophosphamide
Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma
Ewing Sarcoma, EWS, Solid Tumor, Recurrent Solid Tumors, Refractory Solid Tumors, Bone Cancer, Bone Tumor, Bone Sarcoma, Soft Tissue Cancer, Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Pediatric Cancer, Childhood Cancer, Ewing Sarcoma Treatment, Palbociclib, CDK4/6 Inhibitor, Irinotecan, Temozolomide, Topotecan, Cyclophosphamide
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Show 108 locations
Study Locations
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| Location | Contacts |
|---|---|
| Alberta Children's Hospital Calgary, Alberta | |
| All India Institute of Medical Sciences Bhubaneswar, | |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | |
| Arnold Palmer Hospital for Children Orlando, Florida | |
| Artemis Hospital Gurgaon, Haryana | |
| Asan Medical Center Seoul, | |
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone Marseille, | |
| Astrid Lindgrens Barnsjukhus Stockholm, | |
| BIONT, a.s. Bratislava, | |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház Miskolc, Borsod-abaúj-zemplén | |
| Buerger Center for Advanced Pediatric Care Philadelphia, Pennsylvania | |
| CHU Sainte-Justine Montréal, Quebec | |
| Carolinas Medical Center/Levine Children's Hospital Charlotte, North Carolina | |
| Children's Blood and Cancer Center Austin, Texas | |
| Children's Healthcare of Atlanta at Egleston Atlanta, Georgia | |
| Children's Healthcare of Atlanta at Scottish Rite Atlanta, Georgia | |
| Children's Healthcare of Atlanta, Medical Office Building Atlanta, Georgia | |
| Children's Hospital Colorado Aurora, Colorado | |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital and Research Center at Oakland Oakland, California | |
| Children's Hospital of Orange County Orange, California | |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Children's Hospital of the King's Daughters Norfolk, Virginia | |
| Children's Medical Center Dallas Dallas, Texas | |
| Children's Medical Center Plano Plano, Texas | |
| Children's Mercy Hospital Kansas City, Missouri | |
| Children's National Medical Center Washington D.C., District of Columbia | |
| Children's Of Alabama Birmingham, Alabama | |
| Children's Wisconsin Milwaukee, Wisconsin | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| Cincinnati Children's Liberty Campus Liberty Township, Ohio | |
| Cohen Children's Medical Center New Hyde Park, New York | |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's H/O Infusion Center Grapevine, Texas | |
| Cook Children's Medical Center Fort Worth, Texas | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dell Children's Medical Center Austin, Texas | |
| Detska Fakultna nemocnica s poliklinikou Banska Bystrica Banska Bystrica, | |
| Ege Universitesi Hastanesi Izmir, | |
| Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica, Oddelenie radiologie Banska Bystrica, | |
| Fakultni nemocnice v Motole Prague, | |
| Fundação Pio XII - Hospital de Câncer de Barretos Barretos/SP, São Paulo | |
| Gustave Roussy Villejuif, | |
| Hacettepe Universite Hastaneleri Ankara, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hospital Infantil Universitario Nino Jesus Madrid, | |
| Hospital Sant Joan de Deu Esplugues de Llobregat, Barcelona | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitari i Politécnic La Fe Valencia, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Indiana University Indianapolis, Indiana | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux, Aquitaine | |
| Institut nuklearnej a molekularnej mediciny Banska Bystrica, | |
| Instytut Matki i Dziecka Warsaw, Mazowieckie | |
| Intermountain - Primary Children's Hospital Salt Lake City, Utah | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | |
| Johns Hopkins All Children's Outpatient Care Center Saint Petersburg, Florida | |
| Johns Hopkins University Baltimore, Maryland | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Lucile Packard Children's Hospital Stanford, California | |
| Mayo Clinic in Rochester, Minnesota Rochester, Minnesota | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| MemorialCare Health System - Long Beach Medical Center Long Beach, California | |
| Montefiore Medical Center The Bronx, New York | |
| Morgan Stanley Children's Hospital of New York-Presbyetrian Hospital New York, New York | |
| Narodny ustav detskych chorob Bratislava, | |
| Narodny ustav detskych chorob Bratislava, | |
| National Cancer Center Gyeonggi-do, | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Norton Children's Hospital Louisville, Kentucky | |
| Novak Center for Children's Health Louisville, Kentucky | |
| Oregon Health & Science University Portland, Oregon | |
| Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, | |
| Penn State Children's Hospital and Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania | |
| Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania | |
| Phoenix Children's Hospital Phoenix, Arizona | |
| Primary Children's Hospital Outpatient Services Salt Lake City, Utah | |
| Rajiv Gandhi Cancer Institute And Research Centre Delhi, | |
| Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| SUNY Upstate Medical University Syracuse, New York | |
| Sahlgrenska Universitetssjukhuset Östra Gothenburg, | |
| Samsung Medical Center Seoul, | |
| Seattle Children's Hospital Seattle, Washington | |
| Seoul National University Hospital Seoul, | |
| Stollery Children's Hospital Edmonton, Alberta | |
| Texas Children's Hospital Houston, Texas | |
| The Hospital for Sick Children Toronto, Ontario | |
| Torrence E. Hemby Jr. Pediatric Hematology & Oncology Center Charlotte, North Carolina | |
| UCSF Medical Center San Francisco, California | |
| UF Health Shands Hospital Gainesville, Florida | |
| UMHAT Tsaritsa Yoanna-ISUL EAD Sofia, | |
| UPMC Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of California San Francisco, San Francisco, California | |
| University of Florida College of Medicine Jacksonville, Florida | |
| University of Illinois College of Medicine at Peoria Peoria, Illinois | |
| University of Michigan Health System Ann Arbor, Michigan | |
| University of Minnesota Minneapolis, Minnesota | |
| University of Minnesota Masonic Children's Hospital Minneapolis, Minnesota | |
| University of Minnesota Medical Center, Fairview Minneapolis, Minnesota | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw, | |
| Washington University School of Medicine St Louis, Missouri |
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Griffin, Jordyn
NCT03959085
HM20018568
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Inclusion Criteria:
* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.
* APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.
* Patients must be \> 365 days and \< 25 years of age
* White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):
* Age 1-9.99 years: WBC \>= 50,000/uL
* Age 10-24.99 years: Any WBC
* Age 1-9.99 years: WBC \< 50,000/uL with:
* Testicular leukemia
* CNS leukemia (CNS3)
* Steroid pretreatment.
* White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):
* Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction.
* Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \[WHO\] 2016 criteria) with \>= 25% blasts on a bone marrow (BM) aspirate;
* OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;
* OR A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.
* Patient has newly diagnosed B-LLy Murphy stages III or IV.
* Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.
* Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.
* Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.
Exclusion Criteria:
* Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group).
* With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.
* Patients who have received \> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
* Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \> 1,000/uL circulating leukemia cells.
* Patients with acute undifferentiated leukemia (AUL) are not eligible.
* For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply:
* T-lymphoblastic lymphoma.
* Morphologically unclassifiable lymphoma.
* Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.
* Patients with known Charcot-Marie-Tooth disease.
* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.
* Patients requiring radiation at diagnosis.
* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
* Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males. PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Bone Scan, DRUG: Calaspargase Pegol, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, BIOLOGICAL: Inotuzumab Ozogamicin, DRUG: Leucovorin Calcium, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Pegaspargase, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy, RADIATION: Radiation Therapy, DRUG: Thioguanine, DRUG: Vincristine Sulfate
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
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Show 230 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Monash Medical Center-Clayton Campus Clayton, Victoria | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Naval Medical Center -San Diego San Diego, California | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Northwestern Medicine Central DuPage Hospital Winfield, Illinois | Site Public Contact - (Claudine.Gamster@CadenceHealth.org) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Palms West Radiation Therapy Loxahatchee Groves, Florida | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Royal Children's Hospital Parkville, Victoria | Site Public Contact - (Jordan.Hansford@rch.org.au) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Saskatoon Cancer Centre Saskatoon, Saskatchewan | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Starship Children's Hospital Grafton, Auckland | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | |
| Sutter Medical Center Sacramento Sacramento, California | |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | |
| University Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vannie Cook Children's Clinic McAllen, Texas | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wesley Medical Center Wichita, Kansas | Site Public Contact - (WesleyResearch@wesleymc.com) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | |
| Women's and Children's Hospital-Adelaide North Adelaide, South Australia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Caring and Coping with Cancer (C3) (C3)
Winter, Marcia - mawinter@vcu.edu
Winter, Marcia
14620
HM20014307
Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Non-Hodgkin's Lymphoma
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Winter, Marcia - (mawinter@vcu.edu) |
Expanded Access of Obinutuzumab in a Patient Who Responded to Treatment While on a Clinical Trial
ctrrecruit@vcu.edu
Yazbeck, Victor, Y
14756
HM20015975
drug: Obinutuzumab, Modality: Chemotherapy (nos)
Non-Hodgkin's Lymphoma
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia |
Distress in the Pediatric Oncology Setting: Intervention versus Natural Adaptation
Jewell, Andrea - Andrea.Jewell@vcuhealth.org
Rohan, Jennifer
NCT04409301
HM20019000
Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Breast, Brain and Nervous System, Bones and Joints, Anus, Any Site, Non-Hodgkin's Lymphoma, Other Digestive Organ, Other Female Genital, Other Endocrine System, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Urinary, Other Skin, Other Respiratory and Intrathoracic Organs, Other Male Genital, Other Hematopoietic
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Jewell, Andrea - (Andrea.Jewell@vcuhealth.org) |
Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source (CivaSheet)
Carra Castagnero - ccastagnero@civatechoncology.com
Fields, Emma, C
NCT02843945
HM20010844
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Inclusion Criteria:
* • Subject signed inform consent
* Age \> 18 years
* Not pregnant or breast feeding
* Patient capable of undergoing anesthesia
* Patient selected to undergo Whipple procedure or distal pancreatectomy
* Patient does not have metastatic disease
* Patients will have close margins
* No prior radiation therapy to the region for separate cancer
* Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
* Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
* Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
* Gemcitabine + nb-paclitaxel
* FOLFIRINOX
* Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
* up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil
Exclusion Criteria:
* Not surgical candidate
* Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
* An IRE candidate (IRE is Percutaneous irreversible electroporation)
* Recurrent or previously resected tumors
* Documented History of Alcoholism and or drug abuse
* Participant in other clinical trials DEVICE: Directional Brachytherapy Source Implant
Pancreatic Cancer
brachytherapy, CivaSheet, CivaTech, whipple, radiation, borderline resectable, locally advanced, Pd-103, intraoperative radiation
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Study Locations
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| Location | Contacts |
|---|---|
| Advocate Christ Medical Center Oak Lawn, Illinois | Colleen Valenti, OCN - (colleen.valenti@advocatehealth.com) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Rush University Cancer Center Chicago, Illinois | |
| Tampa General Hospital Tampa, Florida | Raegen Einsmann - (reinsmann@usf.edu) |
| University Medical Center LSU New Orleans, Louisiana | |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia |
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Gowda, Madhu, S
NCT03126916
HM20015351
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Inclusion Criteria:
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916)
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patient must be \>= 365 days and =\< 30 years of age at diagnosis
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible:
* Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:
* MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
* Age \> 547 days regardless of biologic features
* Patients with INRG stage MS disease with MYCN amplification
* Patients with INRG stage L2 disease with MYCN amplification
* Patients \> 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within 4 weeks of progression to stage M
* Patients \>= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within 4 weeks of progression to stage M
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing); patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high risk disease but subsequently found to meet the criteria will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/sex as follows:
* 1 to \< 2 years: male = 0.6; female = 0.6
* 2 to \< 6 years: male = 0.8; female = 0.8
* 6 to \< 10 years: male = 1; female = 1
* 10 to \< 13 years: male = 1.2; female = 1.2
* 13 to \< 16 years: male = 1.5; female = 1.4
* \>= 16 years: male = 1.7; female = 1.4
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \> 50% by echocardiogram or radionuclide angiogram
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): See ANBL2131 (NCT06172296) protocol for eligible high-risk neuroblastoma diagnoses
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In addition, all patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) Arm E must have tumors with an ALK aberration
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Given the lack of data with lorlatinib in infant populations, patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) must be \> 1 year of age at time of transfer to ANBL1531 (NCT03126916). Patients \< 1 year of age found to have a qualifying ALK alteration as part of ANBL2131 (NCT06172296) may continue to participate in ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients initially recognized to have high-risk disease must have received no more than one cycle of topotecan/cyclophosphamide either after enrollment to ANBL2131 (NCT06172296) or started emergently prior to enrollment to ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received up to one cycle of intermediate risk chemotherapy prior to initial enrollment to ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In order to facilitate patient transfer and ensure timely distribution of lorlatinib, there are no blood count requirements to meet at time of transfer from ANBL2131 (NCT06172296) to ANBL1531 ((NCT03126916) Arm E. Note the blood count criteria that must be met prior to start of Induction cycle 2 on Arm E. Lorlatinib therapy should start no sooner than day 1 of Induction cycle 2
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known irreversible grade 2 or greater atrioventricular (AV) block
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Due the potential psychiatric risks from lorlatinib, patients should not have a personal history of a serious psychiatric disorder requiring pharmacologic intervention or severe enough to be considered life-threatening
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution deems feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
Exclusion Criteria:
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with bone marrow failure syndromes
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Lactating females who plan to breastfeed their infants
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have previously received treatment with lorlatinib or other ALK inhibitor
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have undergone treatment arm randomization callback or started induction cycle 2 on ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients with bone marrow failure syndromes
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Lactating females who plan to breastfeed their infants
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration and Biopsy, DRUG: Busulfan, DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Dexrazoxane Hydrochloride, BIOLOGICAL: Dinutuximab, DRUG: Doxorubicin Hydrochloride, PROCEDURE: Echocardiography Test, DRUG: Etoposide Phosphate, RADIATION: External Beam Radiation Therapy, RADIATION: Iobenguane I-123, RADIATION: Iobenguane I-131, DRUG: Isotretinoin, DRUG: Lorlatinib, PROCEDURE: Magnetic Resonance Imaging, DRUG: Melphalan Hydrochloride, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Positron Emission Tomography, BIOLOGICAL: Sargramostim, PROCEDURE: Therapeutic Conventional Surgery, DRUG: Thiotepa, DRUG: Topotecan Hydrochloride, DRUG: Vincristine Sulfate
Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, Neuroblastoma
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Show 161 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CancerCare Manitoba Winnipeg, Manitoba | |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Hospital for Sick Children Toronto, Ontario | |
| IWK Health Centre Halifax, Nova Scotia | |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingston Health Sciences Centre Kingston, Ontario | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Michigan State University East Lansing, Michigan | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center -San Diego San Diego, California | |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
Cady P Noda, Pharm.D. - cady.noda@vcuhealth.org
Noda, Cady, Ploessl
NCT03964259
HM20016430
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Inclusion Criteria:
• Diagnosis of lymphoma or acute lymphoblastic leukemia
• Candidate for a minimum of 2 cycles HDMTX (5 g/m2) in the inpatient setting
• Creatinine clearance ≥ 65 mL/min by modified Schwartz equation
• Patients of childbearing potential must have a negative pregnancy test (serum or urine)
• Lactating female patients must agree not to nurse a child while on this trial
• All patients and/or their parents or legal guardians must provide written informed consent, with assent provided if applicable
Exclusion Criteria:
• Trisomy 21
• History of dialysis within 30 days prior to study registration or currently on dialysis
• Polyuric renal dysfunction
• Pregnancy
• Known or suspected pleural effusion
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Drug: Intravenous fluids
Lymphoma, Acute Lymphoblastic Leukemia, Pediatric Cancer, Pediatric ALL, Pediatric Lymphoma
High Dose Methotrexate, HDMTX, Intravenous Fluids
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond Richmond, Virginia | Lindsey B Gwaltney, RN - (lbgwaltney@vcu.edu) Cady P Noda, Pharm.D. - (cady.noda@vcuhealth.org) |
A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Reference Study ID Number: NP30179 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com
Yazbeck, Victor, Y
NCT03075696
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Inclusion Criteria:
• Depending upon study part, a history or status of: 1) a histologically-confirmed hematological malignancy that is expected to express cluster of differentiation (CD)20; 2) relapse after or failure to respond to at least one prior treatment regimen; and 3) no available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant [ASCT])
• Measurable disease, defined as at lease one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measureable extranodal lesion, defined as > 1.0 cm in its longest dimension
• Able to provide a fresh biopsy from a safely accessible site, per investigator determination, providing the patient has more than one measurable target lesion
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of >/=12 weeks
• AEs from prior anti-cancer therapy must have resolved to Grade less than or equal to ( • Adequate liver, hematological and renal function
• Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic Hepatitis B virus (HBV) infection
• Negative test results for Hepatitis C virus (HCV) and human immunodeficiency virus (HIV)
• Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential. Women who are not of childbearing potential who are considered to be post-menopausal (at least 12 months of non-therapy amenorrhea) or surgically sterile (absence of ovaries and/or uterus) are not required to have a pregnancy test
Exclusion Criteria:
• Inability to comply with protocol mandated hospitalizations and restrictions
• Participants with chronic lymphocytic leukemia (CLL), Burkitt lymphoma and lymphoplasmacytic lymphoma
• Participants with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
• Participants with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to obinutuzumab infusion or by clinical judgment in the absence of a positive blood culture
• Participants with known active infection, or reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing
• Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (e.g., anti-cytotoxic T-lymphocyte-associated protein 4 [anti-CTLA4], anti-programmed death 1 [anti-PD1] and anti-programmed death ligand 1 [anti-PDL1]) within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion on Cycle 1 Day -7
• History of treatment-emergent immune-related AEs associated with prior immunotherapeutic agents
• Documented refractoriness to an obinutuzumab-containing regimen
• Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent, including chimeric antigen receptor therapy (CAR-T) within 4 weeks prior to obinutuzumab infusion
• Prior solid organ transplantation
• Prior allogeneic SCT
• Autologous SCT within 100 days prior to obinutuzumab infusion
• Participant with history of confirmed progressive multifocal leukoencephalopathy (PML)
• Current or past history of central nervous system (CNS) lymphoma
• Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a past history of stroke that have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits are allowed.
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
• Participants with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence)
• Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
• Administration of a live, attenuated vaccine within 4 weeks before obinutuzumab infusion or anticipation that such a live attenuated vaccine will be required during the study
• Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within two weeks prior to obinutuzumab infusion. Treatment with corticosteroid • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
• History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus, erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Participants with a remote history of, or well controlled autoimmune disease, may be eligible to enroll after consultation with the Medical Monitor
• In Part III DLBCL dexamethasone cohort, patients with a history of hypersensitivity to dexamethasone or systemic corticosteroids will be excluded
Drug: Glofitamab, Drug: Obinutuzumab, Drug: Tocilizumab
Non-Hodgkin's Lymphoma
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Show 41 locations
Study Locations
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| Location | Contacts |
|---|---|
| A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia Torino, Piemonte | |
| AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia Ravenna, Emilia-Romagna | |
| Allegheny Health Network (Pittsburg PA) Pittsburgh, Pennsylvania | |
| Auckland Cancer Trial Centre; Ward 64, Auckland City Hospital, Auckland, | |
| CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte Rennes, | |
| CHU Saint Eloi; Service d'Hématologie Clinique Montpellier, | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz Warszawa, | |
| Ch Lyon Sud; Hemato Secteur Jules Courmont Pierre Benite, | |
| China Medical University Hospital; Oncology and Hematology Taichung, | |
| Cliniques Universitaires St-Luc Brussels, | |
| Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia Milano, Lombardia | |
| Helsinki University Central Hospital; Dept of Oncology Helsinki, | |
| Hopital Claude Huriez; Hematologie Lille, | |
| Hopital Henri Mondor; Hematologie Clinique Creteil, | |
| Hospital Duran i Reynals L'Hospitalet; Hematology Department L'Hospitalet de Llobregat, Barcelona | |
| Hospital Univ. 12 de Octubre; Servicio de Hematologia Madrid, | |
| Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia Badalona, Barcelona | |
| Hospital Universitari Vall d'Hebron; Servicio de Hematologia Barcelona, | |
| Hospital Universitario Marques de Valdecilla; Servicio de Hematologia Santander, Cantabria | |
| Hospital del Mar; Servicio de Hematologia Barcelona, | |
| Hunstman Cancer Institute Salt Lake City, Utah | |
| Ingalls Memorial Hospital Harvey, Illinois | |
| Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia Rozzano, Lombardia | |
| MSKCC New York, New York | |
| Mount Sinai Medical Center Miami Beach, Florida | |
| National Taiwan Universtiy Hospital; Division of Hematology Taipei, | |
| Peter MacCallum Cancer Centre Melbourne, | |
| Prince of Wales Hospital; Haematology Randwick, New South Wales | |
| Princess Margaret Cancer Center Toronto, | |
| Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT København Ø, | |
| Swedish Cancer Inst. Seattle, Washington | |
| Szpital Kliniczny im. Heliodora Święcickiego; Oddzial Hematologii i Transplantacji Szpiku Poznań, | |
| UZ Gent Ghent, | |
| University of Kansas Medical Centre Kansas City, Kansas | |
| University of Michigan Ann Arbor, Michigan | |
| Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Wrocław, | |
| Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz Gdańsk, | |
| Virginia Commonwealth University Medical Center Richmond, Virginia | |
| Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK Praha 2, | |
| Washington University; Wash Uni. Sch. Of Med Saint Louis, Missouri |
A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer
Reference Study ID Number: YO40482 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com
NCT03695380
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Inclusion Criteria
• Ability to comply with the study protocol, in the investigator's judgment
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the completion of patient-reported outcome questionnaires
• Histological diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
• Previous treatment with a minimum of one and a maximum of two prior platinum based treatment regimens
• Platinum-sensitive disease
• Availability of tumor biopsy tissue prior to first dose of study treatment with confirmation by the central laboratory that the sample is not only of adequate quality but also assignable to a molecularly defined subgroup based on breast cancer susceptibility gene (BRCA) and loss of heterozygosity (LOH) status
• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
• Adequate hematologic and organ function
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Life expectancy of at least 12 weeks
• Resolved or stabilized toxicities resulting from previous therapy to Grade 1
• Negative HIV test at screening
• Negative hepatitis B surface antigen and total hepatitis B core antibody (HBcAb) test, or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) DNA < 500 IU/mL test at screening
• Negative hepatitis C virus (HCV) antibody test, or positive HCV antibody test followed by a negative HCV RNA test at screening
• For women of childbearing potential: Women must remain abstinent or use two contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 3 months after the last dose of cobimetinib, 6 months after the last dose of niraparib, and 5 months after the last dose of atezolizumab. Women must refrain from donating eggs during this same period Exclusion Criteria
• Prior treatment with mitogen-activated protein kinase inhibitor, polyadenosine diphosphate-ribose polymerase inhibitor, or immune checkpoint inhibitor therapies
• Prior chemotherapy, hormonal therapy, radiotherapy, antibody therapy, or other immunotherapy, gene therapy, vaccine therapy, or treatment with experimental drugs within 14 days prior to first dose of study treatment
• Treatment with systemic immunostimulatory agents within 28 days or 5 half-lives of the drug prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication 14 days prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the study
• History of other malignancy that could affect compliance with the protocol or interpretation of results, or known to have potentially fatal outcome
• Symptomatic and/or untreated central nervous system metastases
• Surgical procedure, significant traumatic injury within 14 days prior to enrollment, or anticipation of need for major surgical procedure during the study
• Minor surgical procedure within 3 days
• History or evidence of retinal pathology on ophthalmic examination
• Left ventricular ejection fraction below institutional lower limit of normal
• History of clinically significant cardiovascular dysfunction
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan
• History or evidence of inherited bleeding diathesis or significant coagulopathy at risk for bleeding
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, or to any component of the atezolizumab formulation
• Known allergy or hypersensitivity to any component of the cobimetinib or niraparib formulation
• Active or history of autoimmune disease or immune deficiency including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barre syndrome, or multiple sclerosis
• Uncontrolled serious medical or psychiatric illness
• History of malabsorption or other condition that would interfere with absorption of oral study drugs, including preexisting duodenal stent or ongoing intestinal obstruction
• Active tuberculosis
• Severe infection within 14 days prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
• Treatment with therapeutic oral or IV antibiotics within 7 days prior to initiation of study treatment
• Treatment with a live, attenuated influenza vaccine within 28 days prior to study treatment initiation, at any time during the study, and for at least 5 months after the last dose of study drug
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
• Previous treatment with strong CYP3A inhibitors (such as ketoconazole and clarithromycin), strong CYP3A inducers (such as carbamazepine and phenytoin), and moderate CYP3A inducers (such as efavirenz, modafinil) within 7 days prior to the initiation of study treatment or with ongoing requirements for these medications
• Pregnancy or breastfeeding, or intention to become pregnant during the study
• Ability to comply with the study protocol, in the investigator's judgment
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the completion of patient-reported outcome questionnaires
• Histological diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
• Previous treatment with a minimum of one and a maximum of two prior platinum based treatment regimens
• Platinum-sensitive disease
• Availability of tumor biopsy tissue prior to first dose of study treatment with confirmation by the central laboratory that the sample is not only of adequate quality but also assignable to a molecularly defined subgroup based on breast cancer susceptibility gene (BRCA) and loss of heterozygosity (LOH) status
• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
• Adequate hematologic and organ function
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Life expectancy of at least 12 weeks
• Resolved or stabilized toxicities resulting from previous therapy to Grade 1
• Negative HIV test at screening
• Negative hepatitis B surface antigen and total hepatitis B core antibody (HBcAb) test, or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) DNA < 500 IU/mL test at screening
• Negative hepatitis C virus (HCV) antibody test, or positive HCV antibody test followed by a negative HCV RNA test at screening
• For women of childbearing potential: Women must remain abstinent or use two contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 3 months after the last dose of cobimetinib, 6 months after the last dose of niraparib, and 5 months after the last dose of atezolizumab. Women must refrain from donating eggs during this same period Exclusion Criteria
• Prior treatment with mitogen-activated protein kinase inhibitor, polyadenosine diphosphate-ribose polymerase inhibitor, or immune checkpoint inhibitor therapies
• Prior chemotherapy, hormonal therapy, radiotherapy, antibody therapy, or other immunotherapy, gene therapy, vaccine therapy, or treatment with experimental drugs within 14 days prior to first dose of study treatment
• Treatment with systemic immunostimulatory agents within 28 days or 5 half-lives of the drug prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication 14 days prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the study
• History of other malignancy that could affect compliance with the protocol or interpretation of results, or known to have potentially fatal outcome
• Symptomatic and/or untreated central nervous system metastases
• Surgical procedure, significant traumatic injury within 14 days prior to enrollment, or anticipation of need for major surgical procedure during the study
• Minor surgical procedure within 3 days
• History or evidence of retinal pathology on ophthalmic examination
• Left ventricular ejection fraction below institutional lower limit of normal
• History of clinically significant cardiovascular dysfunction
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan
• History or evidence of inherited bleeding diathesis or significant coagulopathy at risk for bleeding
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, or to any component of the atezolizumab formulation
• Known allergy or hypersensitivity to any component of the cobimetinib or niraparib formulation
• Active or history of autoimmune disease or immune deficiency including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barre syndrome, or multiple sclerosis
• Uncontrolled serious medical or psychiatric illness
• History of malabsorption or other condition that would interfere with absorption of oral study drugs, including preexisting duodenal stent or ongoing intestinal obstruction
• Active tuberculosis
• Severe infection within 14 days prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
• Treatment with therapeutic oral or IV antibiotics within 7 days prior to initiation of study treatment
• Treatment with a live, attenuated influenza vaccine within 28 days prior to study treatment initiation, at any time during the study, and for at least 5 months after the last dose of study drug
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
• Previous treatment with strong CYP3A inhibitors (such as ketoconazole and clarithromycin), strong CYP3A inducers (such as carbamazepine and phenytoin), and moderate CYP3A inducers (such as efavirenz, modafinil) within 7 days prior to the initiation of study treatment or with ongoing requirements for these medications
• Pregnancy or breastfeeding, or intention to become pregnant during the study
Drug: Cobimetinib, Drug: Niraparib, Drug: Atezolizumab
Ovarian Cancer
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Show 29 locations
Study Locations
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| Location | Contacts |
|---|---|
| Centre Hospitalier Lyon Sud Pierre-Bénite, | |
| Centro Oncologico de Galicia COG; Medical Oncology A Coruna, LA Coruña | |
| Clinica Universidad de Navarra Madrid; Servicio de Oncología Madrid, | |
| Columbia University Medical Center New York, New York | |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia Jaen, | |
| Florida Hospital Cancer Institute; Clinical Research Department Orlando, Florida | |
| Fondazione Policlinico Universitario "A. Gemelli"; Unità di Fase 1: Unità di Farmacologia Clinica Rome, Lazio | |
| Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale Paris, | |
| Hospital Clinico San Carlos; Servicio de Oncologia Madrid, | |
| Hospital Clínico Universitario de Valencia; Servicio de Oncología Valencia, | |
| Hospital Ramon y Cajal; Servicio de Oncologia Madrid, | |
| Hospital Universitari Vall dHebron; Oncology Barcelona, | |
| ICO Girona Girona, | |
| Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest Bordeaux, | |
| Istituto Europeo di Oncologia; Svil. Nuovi Farmaci per Terapie Innovative Milano, Lombardia | |
| Istituto Nazionale Tumori Fondazione G. Pascale Napoli, Campania | |
| Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica Milano, Lombardia | |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland | |
| Jordan Center for Gynecologic Cancers Philadelphia, Pennsylvania | |
| Mayo Clinic-Jacksonville Jacksonville, Florida | |
| Medical College of Georgia; Obstetrics & Gynecolog Augusta, Georgia | |
| Medical College of Wisconsin; Department of Obstetrics and Gynecology Milwaukee, Wisconsin | |
| Moores Cancer Center at UC San Diego Health La Jolla, California | |
| Stephenson Cancer Center Investigational Pharmacy Oklahoma City, Oklahoma | |
| Sutter Health Sacramento, California | |
| Tennessee Oncology; Sarah Cannon Research Institute Nashville, Tennessee | |
| University of Arizona Cancer Center, North Tucson, Arizona | |
| VCU Massey Cancer Center, Dalton Oncology Clinic Richmond, Virginia | |
| Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology Saint Louis, Missouri |
NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors (NOURISH-T+)
Marilyn Stern, PhD - mstern1@usf.edu
Mazzeo, Suzanne, E
NCT04656496
HM20019104
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Inclusion Criteria:
Eligible Pediatric Cancer Survivors must be:
• 5-14 years of age at enrollment;
• Off active treatment for at least 6 months;
• At or above the 85th BMI %ile;
• Able to complete assessments with the help of clinic staff and the USF research team;
• Residing with the participating parent;
• Able to engage in PA tailored to current medical status;
• NOT taking medications that affect body weight (e.g., steroids) within 6 months of enrollment, and
• In remission -- PCS who experience a relapse of cancer during the intervention will be excused from further involvement.
• Must be English- or Spanish-speaking Participating Parents must: * Be either biological or adoptive and/or step mothers or fathers and must be permanent legal guardians of the PCS * Be at least 18 years old * Identifies as the main meal preparer at home * Must be English- or Spanish-speaking
Exclusion Criteria:
* Parents are ineligible if they are non-ambulatory and/or do not reside at least 50% of the time with their participating child.
* Female parents who are currently pregnant will be excluded from the study.
* Children are ineligible to participate if they are non-ambulatory. In addition, children who are wards of the state will be excluded from the study. BEHAVIORAL: NOURISH-T+, BEHAVIORAL: Brief NOURISH-T+
Obesity, Childhood, Cancer, Survivorship
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Show 10 locations
Study Locations
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| Location | Contacts |
|---|---|
| Children's National Hospital Washington D.C., District of Columbia | Catriona Mowbray, PhD - (CMowbray@childrensnational.org) Joanna Nicole Courtis - (jcourtis@childrensnational.org) |
| Emory University Atlanta, Georgia | Jordan Marchak, PhD - (jgillel@emory.edu) Ebonee Harris - (ebonee.harris@choa.org) |
| Hackensack Meridian Health Hackensack, New Jersey | Katharine R Lange, MD - (katharine.lange@hmhn.org) Alexis Dompor - (alexis.dompor@hmhn.org) |
| Johns Hopkins Medicine Baltimore, Maryland | Kathy Ruble, PhD - (rubleka@jhmi.edu) Destiny Walker - (dwalke64@jhmi.edu) |
| Nicklaus Children's Hospital Miami, Florida | |
| USF Pediatrics Tampa, Florida | |
| University of Florida Health System Gainesville, Florida | Tung T Wynn, MD - (twynn@ufl.edu) Giselle J Moore-Higgs - (mooregj@ufl.edu) |
| University of Miami Health System Miami, Florida | Jennifer Coto, PhD - (jennifercoto@med.miami.edu) Valerie Yunis - (valerie.yunis@miami.edu) |
| Virginia Commonwealth University Richmond, Virginia | |
| Washington University School of Medicine St Louis, Missouri | Shalini Shenoy, MD - (shalinishenoy@wustl.edu) Kara Felts - (feltsk@wustl.edu) |
National Cancer Institute "Cancer Moonshot Biobank" (moonshot)
Castellanos, Natasha, Guzy - castellanosn@vcu.edu
Poklepovic, Andrew, S
NCT04314401
HM20020956
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Inclusion Criteria:
* Is consistent with OR has been diagnosed with one of the following:
* Colorectal cancer: stage IV
* Non-small cell or small cell lung cancer: stage III/IV
* Prostate cancer: metastatic prostate cancer
* Gastric cancer, not otherwise specified (NOS): stage IV
* Esophageal cancer, NOS: stage IV
* Adenocarcinoma of gastroesophageal junction: stage IV
* High grade serous ovarian cancer: stage III/IV
* Invasive breast carcinoma: stage III/IV
* Melanoma: stage III/IV
* Acute myeloid leukemia
* Multiple myeloma
* For the purposes of this study,
* Re-staging is allowed
* Having more than one primary cancer is allowed, if the patient is being treated solely for one of the eligible cancers listed above
* Patient should fit in one of the following four clinical scenarios (a-d)
* Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR
* Scheduled to begin treatment with a new regimen of standard of care therapy OR
* Currently progressing on a regimen of standard of care therapy OR
* Currently being treated with a regimen standard of care therapy, without evidence of progression
* Requirements for fresh tissue biospecimen collections at enrollment:
* For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment
* For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy
* For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure
* For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR
* The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling
* Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state
* Requirements for archival tissue:
* For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE
* For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED
* Pre-existing archival material (formalin-fixed, paraffin-embedded \[FFPE\] block, BM aspirate, or unstained slides) that:
* Contains the cancer type for which the participant is enrolled, and
* Was collected no more than 5 years prior to initiation of therapy, and
* Contains at least a surface area of 5 mm\^2 and optimal surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and
* Contains at least 10% tumor content. 70% tumor content is optimal, and
* No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy
* Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment
* Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection
* Blood collection for clinical scenario d must take place within 4 weeks of enrollment, and while patient is on treatment
* Age 13 or older
* Any sex
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)
* NCI PDMR INCLUSION CRITERIA: Patients with CRC with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
* NCI PDMR INCLUSION CRITERIA: Patients with CRC who are 40 years old or younger at time of collection irrespective of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
* NCI PDMR INCLUSION CRITERIA: Patients with BRCA that are either
* Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+)
* African American with triple negative (ER-PR-HER2-)
* NCI PDMR INCLUSION CRITERIA: Patients with lung cancer (LCA), prostate cancer (PCA), gastroesophageal cancer (GEC), ovarian cancer (OV), acute myeloid leukemia (AML), multiple myeloma (MML)
Exclusion Criteria:
* Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial
* For the purposes of this study, past enrollment in clinical trials whereby the patient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed
* Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
* Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion
* Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use
* Factor X inhibitors are permitted
* Use of anti-platelet drugs are permitted
* Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP)
* NCI PDMR EXCLUSION CRITERIA: Patients with complete response
* NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections
* NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection
* Actively febrile patients with uncertain etiology of febrile episode
* All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection
* No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
* NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HBV/HCV without documented resolution PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, OTHER: Medical Chart Review, PROCEDURE: Paracentesis, PROCEDURE: Positron Emission Tomography
Acute Myeloid Leukemia, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Esophageal Carcinoma, Fallopian Tube Carcinoma, Gastric Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Invasive Breast Carcinoma, Lung Non-Small Cell Carcinoma, Lung Small Cell Carcinoma, Malignant Solid Neoplasm, Melanoma, Metastatic Prostate Carcinoma, Multiple Myeloma, Ovarian Carcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Carcinoma, Stage III Fallopian Tube Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Triple-negative Breast Carcinoma
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Show 152 locations
Study Locations
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| Location | Contacts |
|---|---|
| AIS Cancer Center at San Joaquin Community Hospital Bakersfield, California | |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Audie L Murphy VA Hospital San Antonio, Texas | |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Bayhealth Hospital Kent Campus Dover, Delaware | Site Public Contact - (clinical_trials@bayhealth.org) |
| Bayhealth Hospital Sussex Campus Milford, Delaware | Site Public Contact - (clinical_trials@bayhealth.org) |
| Blank Children's Hospital Des Moines, Iowa | |
| Boca Raton Regional Hospital Boca Raton, Florida | |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Broward Health North Deerfield Beach, Florida | |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ctsucontact@westat.com) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital at Montefiore The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Chilton Medical Center Pompton, New Jersey | |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CoxHealth South Hospital Springfield, Missouri | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dickinson County Healthcare System Iron Mountain, Michigan | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| ECU Health Medical Center Greenville, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Kinston Kinston, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Good Samaritan Hospital - Cancer Centers of Colorado Lafayette, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis Daphne, Alabama | Site Public Contact - (donna.goggins@infirmaryhealth.org) |
| Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland Saraland, Alabama | Site Public Contact - (donna.goggins@infirmaryhealth.org) |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Hartford Hospital Hartford, Connecticut | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Intermountain Health Platte Valley Hospital Brighton, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| LSU Health Sciences Center at Shreveport Shreveport, Louisiana | |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | Site Public Contact - (underberga@sjchs.org) |
| Lutheran Hospital - Cancer Centers of Colorado Golden, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| MMP Surgical Care Casco Bay Portland, Maine | Site Public Contact - (ClinicalResearch@mmc.org) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Maine Medical Partners Neurology Scarborough, Maine | Site Public Contact - (ClinicalResearch@mmc.org) |
| Maine Medical Partners Surgical Care Portland, Maine | |
| MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - Sanford Sanford, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Franklin Hospital Farmington, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth LincolnHealth Hospital Damariscotta, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Biddeford Biddeford, Maine | |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Stephens Hospital Norway, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Urology - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Waldo Hospital Belfast, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marion L Shepard Cancer Center - ECU Health Beaufort Hospital Washington, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | Site Public Contact - (esmeralda.carrillo@mercy.net) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Hospital Washington Washington, Missouri | |
| Mercy Infusion Center - Chippewa St Louis, Missouri | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mid Coast Hospital Brunswick, Maine | Site Public Contact - (ctsucontact@westat.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Mobile Infirmary Medical Center Mobile, Alabama | |
| Monongalia Hospital Morgantown, West Virginia | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska | |
| Newton Medical Center Newton, New Jersey | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Novant Health Cancer Institute - Kernersville Kernersville, North Carolina | Site Public Contact - (asmarrs@novanthealth.org) |
| Novant Health Cancer Institute - Mount Airy Mount Airy, North Carolina | Site Public Contact - (asmarrs@novanthealth.org) |
| Novant Health Cancer Institute - Thomasville Thomasville, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Overlook Hospital Summit, New Jersey | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Penobscot Bay Medical Center Rockport, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Physicians' Clinic of Iowa PC Cedar Rapids, Iowa | |
| Prisma Health Baptist Hospital Columbia, South Carolina | |
| Prisma Health Greenville Memorial Hospital Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Roger Williams Medical Center Providence, Rhode Island | Site Public Contact - (fdallesandro@chartercare.org) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| Saint James Community Hospital and Cancer Treatment Center Butte, Montana | |
| Saint Joseph Hospital Lexington, Kentucky | Site Public Contact - (carcieri@sjh-nh.org) |
| Saint Joseph Hospital - Cancer Centers of Colorado Denver, Colorado | |
| Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado | Site Public Contact - (ccrp@co-cancerresearch.org) |
| Saint Mary's Regional Medical Center Reno, Nevada | |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Salinas Valley Memorial Salinas, California | Site Public Contact - (tnielsen2@svmh.com) |
| San Juan City Hospital San Juan, | |
| San Juan Community Oncology Group San Juan, | |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Swedish Covenant Hospital Chicago, Illinois | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Thomas Hospital Fairhope, Alabama | |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Iowa Healthcare Cancer Services Quad Cities Bettendorf, Iowa | Site Public Contact - (katherine-daprile@uiowa.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Veterans Affairs Loma Linda Healthcare System Loma Linda, California |
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Griffin, Jordyn
NCT04293562
HM20020887
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Inclusion Criteria:
* All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
* Patients must be less than 22 years of age at the time of study enrollment
* Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease
* Patient must have 1 of the following:
* \>= 20% bone marrow blasts (obtained within 14 days prior to enrollment)
* In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy
* \< 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
* A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell \[WBC\] count \>= 10,000/uL with \>= 10% blasts or a WBC count of \>= 5,000/uL with \>= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment)
* ARM C: Patient must be \>= 2 years of age at the time of Late Callback
* ARM C: Patient must have FLT3/ITD allelic ratio \> 0.1 as reported by Molecular Oncology
* ARM C: Patient does not have any congenital long QT syndrome or congenital heart block
* ARM C: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
* ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
* ARM C: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
* ARM D: Patient must be \>= 2 years of age at the time of Late Callback
* ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating mutations as reported by Foundation Medicine
* ARM D: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
* ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
* ARM D: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
* NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who transfer to Arm C or Arm D are not eligible
* NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment
* NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking
* NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental retardation)
* NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Fanconi anemia
* Shwachman Diamond syndrome
* Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
* Telomere disorders
* Germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy
* Any concurrent malignancy
* Juvenile myelomonocytic leukemia (JMML)
* Philadelphia chromosome positive AML
* Mixed phenotype acute leukemia
* Acute promyelocytic leukemia
* Acute myeloid leukemia arising from myelodysplasia
* Therapy-related myeloid neoplasms
* Patients with persistent cardiac dysfunction prior to enrollment, defined as ejection fraction (EF) \< 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) \< 24%. \*Note: if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF \>= 50%, the patient is eligible to enroll and may receive an anthracycline-containing Induction regimen
* Administration of prior anti-cancer therapy except as outlined below:
* Hydroxyurea
* All-trans retinoic acid (ATRA)
* Corticosteroids (any route)
* Intrathecal therapy given at diagnosis
* In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be avoided from the time of enrollment until it is determined whether the patient will receive gilteritinib. Patients receiving gilteritinib will be required to avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the study treatment
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
* ARM D: Patient does not have any congenital long QT syndrome or congenital heart block PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation, DRUG: Asparaginase Erwinia chrysanthemi, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexrazoxane Hydrochloride, DRUG: Etoposide, OTHER: Fludeoxyglucose F-18, DRUG: Gemtuzumab Ozogamicin, DRUG: Gilteritinib Fumarate, DRUG: Liposome-encapsulated Daunorubicin-Cytarabine, PROCEDURE: Magnetic Resonance Imaging, DRUG: Methotrexate, DRUG: Mitoxantrone Hydrochloride, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration, DRUG: Therapeutic Hydrocortisone
Acute Myeloid Leukemia
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Show 205 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Palms West Radiation Therapy Loxahatchee Groves, Florida | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | |
| Sydney Children's Hospital Randwick, New South Wales | |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | |
| University Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
EAP for subjects receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Hall, Charles, E. - hallce3@vcu.edu
Simmons, Gary, L.
NCT04771078
HM20021892
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Inclusion Criteria:
• Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria
• Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant
• Clinically stable
Exclusion Criteria:
• Has a hypersensitivity to the active substance or to any of the excipients
• No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel)
• Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement Other protocol-defined inclusion/exclusion criteria apply
Biological: Nonconforming idecabtagene vicleucel,
drug: Idecabtagene vicleucel, Modality: Immunotherapy
Multiple Myeloma
BB2121, Multiple Myeloma, Expanded Access, idecabtagene vicleucel, nonconforming, CAR T, EAP, Pre-Approval Access
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Show 76 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allegheny Health Network Pittsburgh, Pennsylvania | |
| Avera McKennan Hospital & University Health Center Sioux Falls, South Dakota | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Boston Medical Center Boston, Massachusetts | |
| Cancer Center Of Kansas Wichita, Kansas | |
| Cancer Treatment Centers of America, Chicago Zion, Illinois | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| City of Hope cancer Center Duarte, California | |
| Cleveland Clinic Cleveland, Ohio | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Columbia-Presbyterian Medical Center New York, New York | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | |
| Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin | |
| Greenville Health System Greenville, South Carolina | |
| H Lee Moffitt Cancer Center Tampa, Florida | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Hospital Detroit, Michigan | |
| Indiana University Cancer Center Indianapolis, Indiana | |
| Intermountain Healthcare - LDS Hospital Salt Lake City, Utah | |
| Karmanos Cancer Institute Detroit, Michigan | |
| Massachusetts General Hospital / Dana-Farber Cancer Institute Boston, Massachusetts | |
| Mayo Clinic Rochester, Minnesota | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Hollings Cancer Center Charleston, South Carolina | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Methodist Hospital - Texas Transplant Institute San Antonio, Texas | |
| Mount Sinai Hospital New York, New York | |
| New York Presbyterian Cornell University New York, New York | |
| Northside Hospital, Inc Atlanta, Georgia | |
| Ohio State University Wexner Medical Center Columbus, Ohio | |
| Oregon Health and Science University OHSU Portland, Oregon | |
| Providence Portland Medical Center Portland, Oregon | |
| Robert H. Lurie Comprehensive Cancer Center Chicago, Illinois | |
| Roswell Park Cancer Institute Buffalo, New York | |
| Rush University Medical Center Chicago, Illinois | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Sarah Cannon Research Institute Nashville, Tennessee | |
| Spectrum Health Grand Rapids, Michigan | |
| St. David's South Austin Medical Center Austin, Texas | |
| Stanford University Palo Alto, California | |
| Texas Medical Center Houston, Texas | |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas, Texas | |
| The University of Texas - MD Anderson Cancer Center Houston, Texas | |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| UCLA School of Medicine Los Angeles, California | |
| UT Southwestern Medical Center Simmons Comprehensive Cancer Center Dallas, Texas | |
| Univ of AR for Medical Sciences Little Rock, Arkansas | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of Alabama Birmingham, Alabama | |
| University of California San Diego Moores Cancer Center La Jolla, California | |
| University of California San Francisco Medical Center San Francisco, California | |
| University of Chicago Chicago, Illinois | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Illinois Medical Center Chicago, Illinois | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| University of Kansas Medical Center Kansas City, Kansas | |
| University of Kentucky Lexington, Kentucky | |
| University of Maryland - Greenebaum Comprehensive Cancer Center Baltimore, Maryland | |
| University of Massachusetts Worcester, Massachusetts | |
| University of Miami Sylvester Cancer Center Miami, Florida | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Utah - Huntsman Cancer Institute Salt Lake City, Utah | |
| University of Virginia Charlottesville, Virginia | |
| VCU Massey Cancer Center Richmond, Virginia | |
| Virginia Commonwealth University Richmond, Virginia | Hall, Charles, E. - (hallce3@vcu.edu) |
| Washington Univ School of Medicine Siteman Cancer Center Saint Louis, Missouri | |
| West Virginia University - Berkeley Medical Center - Cancer and Infusion Center Morgantown, West Virginia | |
| Winship Cancer Institute of Emory University Atlanta, Georgia | |
| Yale Cancer Center New Haven, Connecticut |
A Phase 1B/2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies (ARTACUS)
Clinical Trials at Replimune - Clinicaltrials@replimune.com
Poklepovic, Andrew, S
NCT04349436
HM20021229
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Key
• Voluntary agreement to provide written informed consent prior to any study procedures and the willingness and ability to comply with all aspects of the protocol and understand the risk to their organ allograft.
• Patients with histologically or cytologically confirmed recurrent, locally advanced or metastatic (to skin, soft tissue or lymph nodes) cutaneous malignancies, including CSCC, basal cell carcinoma, Merkel cell carcinoma, and melanoma
• Patients must have progressed following local resection, prior radiation, topical or systemic therapies.
• Documentation from the patient's transplant physician confirming that the patient's allograft is stable.
• Patients for whom surgical or radiation treatment of lesions is contraindicated.
• At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• Anticipated life expectancy \> 6 months
• Baseline ECG without evidence of acute ischemia.
• All patients must consent to provide archived or newly obtained tumor material (either formalin-fixed, paraffin-embedded \[FFPE\] block or 20 unstained slides). Key
• Prior treatment with an oncolytic therapy.
• Patients with visceral metastases.
• Patients with active herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
• Patients with a history of organ graft rejection within 12 months.
• Had systemic infection requiring intravenous (IV) antibiotics or anti-virals, or other serious infection within 60 days prior to dosing.
• Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g., acyclovir) unless for organ allograft preservation.
• Patients requiring CTLA-4-Ig medications.
• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments beyond that required for maintenance allograft rejection prevention. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that requires only hormone replacement, or psoriasis that does not require systemic treatment.
• Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
• Any history of transplant-related viral infections, such as BKV, EBV or CMV, within 3 months of study entry. Patients with a history of hepatitis B or C virus must have undetectable viral load within 3 months of study entry.
• Patients with a condition requiring an increase in the patient's usual immunosuppressive medications within 60 days of study treatment.
• Known active CNS metastases and/or carcinomatous meningitis.
Inclusion Criteria:
• Voluntary agreement to provide written informed consent prior to any study procedures and the willingness and ability to comply with all aspects of the protocol and understand the risk to their organ allograft.
• Patients with histologically or cytologically confirmed recurrent, locally advanced or metastatic (to skin, soft tissue or lymph nodes) cutaneous malignancies, including CSCC, basal cell carcinoma, Merkel cell carcinoma, and melanoma
• Patients must have progressed following local resection, prior radiation, topical or systemic therapies.
• Documentation from the patient's transplant physician confirming that the patient's allograft is stable.
• Patients for whom surgical or radiation treatment of lesions is contraindicated.
• At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• Anticipated life expectancy \> 6 months
• Baseline ECG without evidence of acute ischemia.
• All patients must consent to provide archived or newly obtained tumor material (either formalin-fixed, paraffin-embedded \[FFPE\] block or 20 unstained slides). Key
Exclusion Criteria:
• Prior treatment with an oncolytic therapy.
• Patients with visceral metastases.
• Patients with active herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
• Patients with a history of organ graft rejection within 12 months.
• Had systemic infection requiring intravenous (IV) antibiotics or anti-virals, or other serious infection within 60 days prior to dosing.
• Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g., acyclovir) unless for organ allograft preservation.
• Patients requiring CTLA-4-Ig medications.
• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments beyond that required for maintenance allograft rejection prevention. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that requires only hormone replacement, or psoriasis that does not require systemic treatment.
• Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
• Any history of transplant-related viral infections, such as BKV, EBV or CMV, within 3 months of study entry. Patients with a history of hepatitis B or C virus must have undetectable viral load within 3 months of study entry.
• Patients with a condition requiring an increase in the patient's usual immunosuppressive medications within 60 days of study treatment.
• Known active CNS metastases and/or carcinomatous meningitis.
BIOLOGICAL: RP1, intra-tumoral injection, oncolytic virus
Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, Basal Cell Carcinoma, Melanoma
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Show 28 locations
Study Locations
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| Location | Contacts |
|---|---|
| Columbia University Medical Center New York, New York | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Duke University Durham, North Carolina | |
| Inova Schar Cancer Institute Fairfax, Virginia | |
| MD Anderson Cancer Center Houston, Texas | |
| Mayo Clinic Arizona Phoenix, Arizona | |
| Mayo Clinic Florida Jacksonville, Florida | |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Medical Dermatology Specialists Phoenix, Arizona | |
| Moffitt Cancer Center Tampa, Florida | |
| Oregon Health and Science University Portland, Oregon | |
| Rochester Dermatologic Surgery New York, New York | |
| The Cleveland Clinic Foundation Cleveland, Ohio | |
| The Ohio State University Comprehensive Cancer Center Columbus, Ohio | |
| UCSF, Helen Diller Family Comprehensive Cancer Center San Francisco, California | |
| University of California, Los Angeles Los Angeles, California | |
| University of California, San Diego La Jolla, California | |
| University of Chicago Chicago, Illinois | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Colorado Cancer Center School of Medicine Aurora, Colorado | |
| University of Miami Sylvester Comprehensive Cancer Center Miami, Florida | |
| University of Michigan Ann Arbor, Michigan | |
| University of North Carolina Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | |
| University of Tennessee Medical Center at Knoxville Knoxville, Tennessee | |
| University of Texas Southwestern Dallas, Texas | |
| VCU Massey Cancer Center Richmond, Virginia | |
| Washington University in St. Louis St Louis, Missouri |
Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol
Hall, Charles, E. - hallce3@vcu.edu
Simmons, Gary, L.
NCT04400591
HM20022052
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Inclusion Criteria:
• Subject and/or LAR must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
• Subject has relapsed and/or refractory large B-cell lymphoma and is, per the treating physician assessment, eligible for treatment with lisocabtagene maraleucel per the approved prescribing information.
• Subject is ? 18 years of age at the time of signing the informed consent form.
• Subject had a specific batch of lisocabtagene maraleucel manufactured intended for commercial treatment; however, the final manufactured product did not meet commercial release criteria.
• Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject.
• Subject is clinically stable, has recovered from any toxicities prior to receiving lymphodepleting chemotherapy, and has adequate bone marrow function to receive lymphodepleting chemotherapy. The treating physician is advised to contact Medical Monitor in the event there is any concern regarding administration of lymphodepleting chemotherapy.
• Females of childbearing potential must:
• Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact.
• Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the nonconforming lisocabtagene maraleucel administration.
• Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming lisocabtagene maraleucel administration.
• There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with lisocabtagene maraleucel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician.
• Male subjects must:
• Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after nonconforming lisocabtagene maraleucel administration even if the subject has undergone a successful vasectomy.
• There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with lisocabtagene maraleucel. Any decision regarding contraception after infusion should be discussed with the treating physician
• Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following nonconforming lisocabtagene maraleucel administration.
Exclusion Criteria:
• Subject has a hypersensitivity to the active substance or to any of the excipients.
• Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of adverse events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming lisocabtagene maraleucel.
• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol complying with protocol requirements in the Investigator's judgement.
• Subject has any condition and/or laboratory abnormality that places the subject at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement
• Pregnant or nursing women or has intention of becoming pregnant during the study.
• Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study).
• Subject has active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of pretreatment evaluation
• Subject has uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of nonconforming lisocabtagene maraleucel administration.
• Subject has presence of acute or chronic graft-versus-host disease (ie, GVHD)
• Use of the following:
• Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 72 hours prior to nonconforming lisocabtagene maraleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted.
• Low dose chemotherapy (eg, vincristine, rituximab, cyclophosphamide ? 300 mg/m2)given after leukapheresis to maintain disease control must be stopped ? 7 days prior to lymphodepleting chemotherapy.
• Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week of LD chemotherapy. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to lymphodepleting chemotherapy.
• Donor lymphocyte infusions within 6 weeks of nonconforming lisocabtagene maraleucel administration.
Biological: Nonconforming Lisocabtagene Maraleucel
Lymphoma, Large B-Cell, Diffuse
Expanded Access, JCAR017, Lisocabtagene Maraleucel, CAR T, nonconforming,, relapsed/refractory diffuse large B cell lymphoma, nonconforming lisocabtagene mareleucel
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Show 76 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allegheny Health Network Pittsburgh, Pennsylvania | |
| Avera Cancer Institute Sioux Falls, South Dakota | |
| Baylor University Medical Center Dallas, Texas | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Cancer Center Of Kansas Wichita, Kansas | |
| Cancer Centre of Excellence - Univ of MA Medical School Worcester, Massachusetts | |
| Cancer Treatment Centers of America, Chicago Zion, Illinois | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Chiba University Hospital Chiba, Chiba | |
| City of Hope Duarte, California | |
| Cleveland Clinic - Taussig Cancer Institute Cleveland, Ohio | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | |
| Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin | |
| Georgetown University Hospital Washington, District of Columbia | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Health System Division of Hematology Oncology Detroit, Michigan | |
| Hokkaido University Hospital Sapporo, Hokkaido | |
| HonorHealth Research Institute Scottsdale, Arizona | |
| Houston Methodist Hospital Houston, Texas | |
| Hyogo College of Medicine Hospital Hyōgo, | |
| Intermountain Healthcare - LDS Hospital Salt Lake City, Utah | |
| Jichi Medical University Hospital Shimotsuge-shi, Tochigi | |
| Kanazawa University Hospital Kanazawa, | |
| Karmanos Cancer Institute Detroit, Michigan | |
| Keio University Hospital Tokyo, | |
| Kindai University Hospital Sakai, | |
| Kumamoto University Hospital Kumamoto, | |
| Kyoto University Hospital Kyoto, | |
| Kyushu University Hospital Fukuoka, | |
| Levine Cancer Institute Charlotte, North Carolina | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | |
| Mayo Clinic Cancer Center Jacksonville, Florida | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Methodist Hospital - Texas Transplant Institute San Antonio, Texas | |
| Moffit Cancer Center Tampa, Florida | |
| Mount Sinai Hospital New York, New York | |
| National Cancer Center Hospital Tokyo, | |
| New York Oncology Hematology P.C. Albany, New York | |
| New York Presbyterian Hospital Weill Medical College Cornell University New York, New York | |
| Northwestern University Medical Center Chicago, Illinois | |
| Okayama University Hospital Okayama, | |
| Oregon Health and Science University Portland, Oregon | |
| Osaka City University Hospital Osaka, | |
| Osaka University Hospital OUH Osaka-Fu, | |
| Prisma Health System - Eastside Cancer Center Greenville, South Carolina | |
| Roswell Park Cancer Center Buffalo, New York | |
| Rush University Medical Center Chicago, Illinois | |
| Sarah Cannon Research Institute Nashville, Tennessee | |
| Spectrum Health Grand Rapids, Michigan | |
| Swedish Cancer Institute Seattle, Washington | |
| The Ohio State University Comprehensive Cancer Center Columbus, Ohio | |
| The University of Texas - MD Anderson Cancer Center Houston, Texas | |
| Tohoku University Hospital Sendai, | |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo, | |
| UT Southwestern Medical Center Dallas, Texas | |
| University Hospitals Case Medical Center Cleveland, Ohio | |
| University of Alabama at Birmingham Hospital Birmingham, Alabama | |
| University of California San Francisco Medical Center San Francisco, California | |
| University of Cincinnati Medical Center Cincinnati, Ohio | |
| University of Colorado Aurora, Colorado | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of North Carolina Chapel Hill, North Carolina | |
| University of Oklahoma Peggy and Charles Stephenson Cancer Center Oklahoma City, Oklahoma | |
| University of Pittsburgh Medical Center Hillman Cancer Center Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| VCU Massey Cancer Center Richmond, Virginia | |
| Virginia Commonwealth University Richmond, Virginia | Hall, Charles, E. - (hallce3@vcu.edu) |
| West Virginia University - Berkeley Medical Center - Cancer and Infusion Center Morgantown, West Virginia | |
| Winship Cancer Institute of Emory University Atlanta, Georgia | |
| Yale University School of Medicine New Haven, Connecticut |
Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (FLORA-5)
Clinical Operations - ClinicalTrialDisclosures@oncoquestinc.com
Randall, Leslie
NCT04498117
HM20021341
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Major
• Adults 18 years old or older.
• Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.
• Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
• Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor).
• Preoperative serum CA- 125 levels ≥ 50 U/mL.
• Adequate bone marrow function:
• Absolute neutrophil count (ANC) greater than or equal to 1,500/µL
• Platelets greater than or equal to100,000/µL
• Hemoglobin greater than or equal to 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
• Adequate liver function:
• Bilirubin < 1.5 times upper limit normal (ULN)
• Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
• Albumin >3.5 g/dL
• Adequate renal function: a. Creatinine less than or equal to1.5 times ULN
• ECOG Performance Status of 0 or 1. Major
• BRCA1 or BRCA2 germline gene mutation test result with:
• Positive, ambiguous or inconclusive result available within 28 days prior to starting study treatment, or
• Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or
• Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy.
• Subjects with mucinous adenocarcinoma and low- grade adenocarcinoma.
• Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for Cohort 1 or C4D1 for Cohort 2).
• Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment.
• Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin.
• Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc. (see Appendix G).
• Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed.)
• Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
• Anticipated treatment with any other anti-cancer medications, including bevacizumab, poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s) during the study.
Inclusion Criteria:
• Adults 18 years old or older.
• Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.
• Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
• Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor).
• Preoperative serum CA- 125 levels ≥ 50 U/mL.
• Adequate bone marrow function:
• Absolute neutrophil count (ANC) greater than or equal to 1,500/µL
• Platelets greater than or equal to100,000/µL
• Hemoglobin greater than or equal to 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
• Adequate liver function:
• Bilirubin < 1.5 times upper limit normal (ULN)
• Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
• Albumin >3.5 g/dL
• Adequate renal function: a. Creatinine less than or equal to1.5 times ULN
• ECOG Performance Status of 0 or 1. Major
Exclusion Criteria:
• BRCA1 or BRCA2 germline gene mutation test result with:
• Positive, ambiguous or inconclusive result available within 28 days prior to starting study treatment, or
• Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or
• Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy.
• Subjects with mucinous adenocarcinoma and low- grade adenocarcinoma.
• Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for Cohort 1 or C4D1 for Cohort 2).
• Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment.
• Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin.
• Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc. (see Appendix G).
• Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed.)
• Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
• Anticipated treatment with any other anti-cancer medications, including bevacizumab, poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s) during the study.
Biological: Oregovomab, Drug: Paclitaxel, Drug: Carboplatin, Biological: Placebo
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Ovarian Cancer, Ovarian Serous Adenocarcinoma, Fallopian Tube Neoplasms, Fallopian Tube Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Peritoneal Cancer, Peritoneal Carcinoma, Peritoneal Neoplasms
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Show 193 locations
Study Locations
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| Location | Contacts |
|---|---|
| AZ Sint-Jan Bruges, | Eveline De Cuypere, MD |
| AdventHealth Orlando Orlando, Florida | Robert Holloway, MD |
| All India Institute of Medical Services Delhi, | Sachin Khurana, MD |
| Asan Medical Center Seoul, | Yong-Man Kim |
| Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) Monza, | Andrea Alberto Lissoni, MD |
| Bacs-Kiskun Megyei Oktatokorhaz Kecskemét, Other | Zsolt Horvath |
| Baylor Scott & White Health Temple, Texas | |
| CEMAIC - Centro Medico Privado Córdoba, Cordoba | Jorge Emilio Salinas, MD |
| CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia Santo André, SP | Patricia Santi |
| CER San Juan Centro Polivalente de Asistencia e Inv. Clinica San Juan, | Juan Manuel Puig, MD |
| CHUM Centre de Recherche (affiliated with University of Montreal) Montréal, Quebec | Diane Provencher, MD, FRCSC |
| CHUS - Hôpital Fleurimont Sherbrooke, Quebec | Paul Bessette, MD |
| Carilion Clinic Gynecological Oncology Roanoke, Virginia | David A Iglesias, MD |
| Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus Porto Alegre, | Christina Pimentel Oppermann |
| Centro Potosino de Investigación Medica S.C. San Luis Potosi, | Dolores Leticia Mendoza Oliva |
| Centro de Estudios Clínicos e Investigación Médica (CeCim) Santiago, | Carla Saavedra, MD |
| Centro de Investigación Clínica Bradford Hill Santiago, | Carlos Rojas |
| Centro de Pesquisa Clinica e Oncologia Guimaraes, Rodrigo | Fabio Andre Franke, MD |
| Centro de Pesquisas Clinica Reichow Blumenau, | Sandro Laercio Reichow |
| China Medical University Hospital Taichung, | Lian-Shung Yeh, MD |
| City of Health Hospital at Laval (Cité de la Santé de Laval) Laval, Quebec | Melanie Arbour-Levert, MD |
| Cleveland Clinic Cleveland, Ohio | Steven Waggoner, MD |
| Cleveland Clinic Fairview Hospital Cleveland, Ohio | Steven Waggoner, MD |
| Cleveland Clinic Hillcrest Hospital Mayfield Heights, Ohio | Steven Waggoner |
| Clinical Medical Research S.C. Orizaba, Veracruz | Jose David Gomez Rangel |
| Clinicas Viedma S.A. Viedma, | Ruben Kowalyszyn |
| Clinique CHC MontLégia Liège, | Maryam Bourhaba |
| Cliniques Universitaires Saint-Luc Brussels, | Jean-François Baurain |
| Clínica São Germano - Oncologia Sao Paulo, | Augusto Takao Rodrigues Pereira |
| Clínica Universitaria Privada Reina Fabiola Córdoba, Cordoba | Santiago Bella, MD |
| Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda. Sao Paulo, | Andre Mattar |
| Contra Costa Oncology Walnut Creek, California | Babak Edraki, MD |
| Debreceni Egyetem Debrecen, | Krasznai Zoard |
| Deenanath Mangeshkar Hospital Pune, | Chetan Dilip Deshmukh, MD |
| Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet Budapest, | Gyorgy Bodoky |
| Diablo Valley Oncology Hematology Medical Group Pleasant Hill, California | Babak Edraki, MD |
| Duke University Durham, North Carolina | Angeles Alvarez Secord, MD |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | Angeles Alvarez Secord, MD |
| Epic Care Pleasant Hill, California | Babak Edraki, MD |
| Fakultni nemocnice Bulovka Prague, | Michael Zikan |
| Fakultni nemocnice Hradec Kralove Hradec Králové, | Jiri Spacek, MD, PhD |
| Fakultni nemocnice Kralovske Vinohrady Prague, | Lukas Rob |
| Fakultni nemocnice Olomouc Olomouc, | Bohuslav Melichar |
| Fakultni nemocnice v Motole Prague, | Jana Prausova, MUDr |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma, | Giovanni Scambia |
| Fortis Hospital Ltd Bengaluru, | Niti Raizada, MD |
| Fortis Hospital Ltd Bengaluru, | Vinayak Munithrathnan, Dr. |
| Fundação Doutor Amaral Carvalho Jaú, | Patricia Medeiros Milhomem Beato |
| GZA Ziekenhuizen Wilrijk, | |
| Grandview Medical Center/Kettering Medical Center Kettering, Ohio | Thomas Reid, MD |
| Gynecological Cancer Institute of Chicago, LLC Oak Lawn, Illinois | Alfred Guirguis, DO |
| H Lee Moffitt Cancer Center and Research Institute Tampa, Florida | Hye Sook Chon, MD |
| H.U. Fundacion Jimenez Diaz Madrid, | Victoria Casado |
| Holy Name Medical Center Teaneck, New Jersey | Sharyn Lewin, MD |
| Honor Health Scottsdale, Arizona | Lyndsay Wilmott, MD |
| Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal Montréal, Quebec | Lara DeGuerke, MD |
| Hospital Clinic de Barcelona Barcelona, | Lydia Gaba Garcia, MD |
| Hospital De La Santa Creu I Sant Pau Barcelona, | Cristina Martin Lorente |
| Hospital General Universitario Gregorio Marañon Madrid, | Sara Perez Ramirez |
| Hospital Santa Marcelina Sao Paulo, | Roberto Odebrecht Rocha |
| Hospital Universitari Vall d'Hebron Barcelona, | Juan Francisco Grau, MD |
| Hospital Universitario 12 de Octubre Madrid, | |
| Hospital Universitario Virgen Macarena Seville, | Teresa Garcia Manrigue |
| Hospital Universitario Virgen de las Nieves Granada, | Lucia Castillo Portellano |
| Hospital de Câncer de Barretos - Fundação Pio XII Barretos, | Marina Costa Zorzetto, MD |
| ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA SĂŁo Paulo, | Elias Abdo Filho |
| ICO l'Hospitalet-Hospital Duran i Reynals L'Hospitalet De Llobregat, | Beatriz Pardo Burdalo |
| INCA - Instituto Nacional de Câncer Rio de Janeiro, | Andréia Cristina de Melo |
| Icahn School of Medicine at Mount Sinai New York, New York | Samanatha Cohen, MD |
| Illinois Cancer Specialists The Woodlands, Texas | Urszula Sobol, MD |
| Instituto Valenciano de Oncologia IVO Valencia, | Ignacio Romero Noguera |
| Instytut Centrum Zdrowia Matki Polki Lodz, | Ewa Kalinka, PhD, MD |
| Investigacion Onco Farmaceutica S. de R.L. de C.V. (OncoTech) La Paz, | Juan Paulo Ceja Garcia |
| John Muir Cancer Specialty Services Concord, California | Babak Edraki, MD |
| John Muir Health Clinical Research Center Concord, California | Babak Edraki, MD Peggy Newsom - (peggy.newsom@johnmuirhealth.com) |
| John Muir Health Gynecologic Cancer Services Walnut Creek, California | Babak Edraki, MD |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Devansu Tewari, MD |
| Kaiser Permanente Riverside Medical Center Riverside, California | Devansu Tewari, MD |
| Kaiser Permanente Southern California Irvine, California | Devansu S Tewari, MD |
| Kapiolani Medical Center for Women and Children/University of Hawaii Honolulu, Hawaii | Michael Carney, MD |
| Karla Adriana Espinosa Bautista Mexico, | Fernando Perez Zincer, MD |
| Koo Foundation Sun Yat-Sen Cancer Center Taipei, | Chi-Feng Chung, MD |
| Korea Univ Anam Hsp Seoul, | Kyong Hwa Park |
| Korea University Guro Hospital Seoul, | Hyun-Woong Cho, MD |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Corrine Zarwan, MD |
| Lewis Cancer & Research Pavilion at St. Joseph's Candler Savannah, Georgia | Sarah Gill, MD - (drgills@sjchs.org) |
| Lowell General Hospital Lowell, Massachusetts | Sarah Paraghamian |
| Magee Women's Hospital of UPMC Pittsburgh, Pennsylvania | Lan G Coffman, MD Brenda Lee Steele, RN,CCRC,CBCN - (steeleb@upmc.edu) |
| Magyar Honvedseg Egeszsegugyi Kozpont Budapest, | Zsuzsanna Papai |
| Max Super Specialty Hospital Mohali, | Gautam Goyal, MD |
| McGill University Health Centre/Glen Site/ Royal Victoria Hospital Montréal, Quebec | Lucy Gilbert, MD |
| Memorial Herman Hospital Houston, Texas | Joseph Lucci |
| Metro Minnesota Community Oncology Research Consortium Saint Louis Park, Minnesota | Jessica Thomas-Pepin, MD |
| MetroWest Medical Center Framingham, Massachusetts | Sarah Paraghamian, MD |
| Minnesota Oncology Hematology Minneapolis, Minnesota | Jessica Thomes-Pepin, MD |
| Minnesota Oncology Hematology Minneapolis, Minnesota | Jessica Thomes-Pepin, MD |
| Minnesota Oncology Hematology Minneapolis, Minnesota | Jessica Thomes-Pepin, MD |
| Minnesota Oncology Hematology - Mercy Hospital Coon Rapids, Minnesota | Jessica Thomes-Pepin, MD |
| Montefiore Medical Center PRIME Bronx, New York | Nicole Nevandusky, MD |
| Moores UC San Diego Cancer Center La Jolla, California | Ramez Eskander, MD |
| Mount Sinai - PRIME Lake Success, New York | Samantha Cohen, MD |
| Mount Sinai The Blavatnik Family Chelsea Medical Center New York, New York | Samantha Cohen, MD |
| MultiCare Institute for Research and Innovation Tacoma, Washington | Christopher Breed, MD Min-Chun Chen, MD |
| MultiCare Regional Cancer Center - Auburn Auburn, Washington | Christopher Breed, MD |
| MultiCare Regional Cancer Center - Tacoma Puyallup, Washington | Christopher Breed, MD |
| MultiCare Regional Cancer Center-Gig Harbor Medical Park Gig Harbor, Washington | Christopher Breed, MD |
| National Cancer Center Gyeonggi-do, | Myong Cheol Lim |
| National Cheng Kung University Hospital Tainan, | Yu-Fang Huang, MD |
| National Taiwan University Hospital Taipei, | Wen-Fang Cheng, MD |
| Nebraska Methodist Hospital Omaha, Nebraska | Brent Tierney |
| Northwest Cancer Specialists, P.C.-Portland-Rose Quarter Portland, Oregon | Erin Salinas, MD |
| Ohio State University Wexner Medical Center Columbus, Ohio | Casey Cosgrove, MD |
| Oklahoma Cancer Specialist and Research Institution, LLC Tulsa, Oklahoma | Michael A Gold, MD |
| Ospedale Clinicizzato SS. Annunziata Chieti, | Michele De Tursi |
| Park Nicollet Frauenshuh Cancer Center Saint Louis Park, Minnesota | Jessica Thomes-Pepin, MD |
| Parkview Research Center Fort Wayne, Indiana | Iwona Podzielinski, MD |
| Portsmouth Regional Hospital Portsmouth, New Hampshire | Sarah Paraghamian, MD |
| Prosalud Valparaíso, | Pamela Salman Boghikian |
| Queen Elizabeth II Health Sciences Centre Halifax, Nova Scotia | Karla Willows, MD |
| Radiotherapy Center Cluj SRL Flore?ti, Comuna Floresti | Andrei Ungureanu, MD |
| Reading Hospital West Reading, Pennsylvania | |
| Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada Littleton, Colorado | Manojkumar Bupathi, MD, MS |
| Ruby Hall Clinic Pune, Maharashtra | Minish Jain |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | Aliza Leiser |
| S.C Centrul de Oncologie Sf. Nectarie S.R.L Craiova, | Michael Schenker, MD, PhD |
| S.C Gral Medical S.R.L Bucuresti, | Cristina Tiut |
| S.C Medisprof S.R.L Cluj-Napoca, | Anghel Adrian Udrea, MD, PhD |
| S.C Oncomed S.R.L Timişoara, | Serban Mircea Negru |
| S.C Oncomed S.R.L Timişoara, | |
| SCC at St. John's Medical Center Westlake, Ohio | Kristine Zanotti, MD |
| SCC at UH Geauga Medical Center Chardon, Ohio | Kristine Zanotti, MD |
| SMIQ S. de R.L. de C.V. Querétaro, | Marco Antonio Garcia Hernandez, MD |
| Samsung Medical Center Seoul, | Byoung-Gie Kim, Dr. |
| Sanatorio Parque S.A Salta, | Miguel Angel Escudero, MD |
| Sanatorio de la Mujer Rosario, Santa Fe Province | Cristina Marcela Nasurdi, MD |
| Sanford Research/USD-Sioux Falls Sioux Falls, South Dakota | Maria Bell, MD |
| Seoul National University Bundang Hospital Seongnam-si, | Yong Beom Kim |
| Seoul National University Hospital Seoul, | Jae-Weon Kim, PhD, MD |
| Severance Hospital Yonsei University Health System Seoul, | Jung-Yun Lee, MD, PhD |
| Severance Hospital, Yonsei University Health System Seoul, | Min Hwan Kim |
| Siedleckie Centrum Onkologii Siedlce, | Lubomir Bodnar |
| Sociedad de Investigaciones Medicas Limitada Temuco, | Eduardo Yañez Ruiz |
| Sparrow Hospital Lansing, Michigan | Rebecca Liu |
| St. Joseph Mercy Hospital Ann Arbor, Michigan | Rebecca Liu, MD |
| St. Mary Mercy Livonia Hospital Livonia, Michigan | Rebecca Liu |
| Stony Brook University Hospital Stony Brook, New York | William Burke |
| Sushrut Hospital Mumbai, | Sangeeta Jiwatani, MD |
| Szent Margit Korhaz Budapest, | Katalin Boer |
| Taichung Veterans General Hospital Taichung, | Chien-Hsing Lu, MD |
| Taipei Veterans General Hospital Taipei, | Peng-Hui Wang, MD |
| Texas Oncology DFWW Bedford, Texas | Mark Messing, MD |
| Texas Oncology San Antonio Medical Center San Antonio, Texas | Alfredo Santillan-Gomez, MD |
| Texas Oncology, P.A. Dallas, Texas | Kristi McIntyre, MD |
| Texas Oncology, P.A. - Austin Austin, Texas | Michael Teneriello, MD |
| Texas Oncology, P.A. - Fort Worth Fort Worth, Texas | Noelle Cloven, MD |
| The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, | SookHee Hong |
| The Queens Medical Center Honolulu, Hawaii | Keith Terada, MD |
| The University of Arizona Cancer Center Tucson, Arizona | Setsuko K Chambers, MD |
| The Valley Hospital (Valley Health) Paramus, New Jersey | Eleonora Teplinsky, MD |
| Tufts Medical Center Boston, Massachusetts | Sarah Paraghamian, MD |
| Tufts Medical Center Cancer Center in Stoneham Stoneham, Massachusetts | Sarah Paraghamian |
| UH Minoff Health Center - Seidman Orange Village, Ohio | Kristine Zanotti, MD |
| UMass Memorial Medical Center Worcester, Massachusetts | Susan Zweizig, MD |
| UPMC Hillman Cancer Center at UPMC Passavant Pittsburgh, Pennsylvania | Lan G Coffman, MD Brenda Lee Steele, RN,CCRC,CBCN - (steeleb@upmc.edu) |
| Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey, | Omar Alejandro Zayas Villanueva |
| Universitair Ziekenhuis Antwerpen (UZA) Edegem, | Sevilay Altintas |
| University Hospitals of Cleveland Cleveland, Ohio | Kristine Zanotti, MD |
| University of California, Davis Comprehensive Cancer Center Sacramento, California | Rebecca Brooks, MD |
| University of Colorado Health Aurora, Colorado | Bradley Behbakht, MD |
| University of Connecticut Health Center Farmington, Connecticut | Molly Brewer, MD |
| University of Minnesota Health - Maple Grove Clinic Maple Grove, Minnesota | Jessica Thomes-Pepin, MD |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Debra Richardson, MD |
| University of Pennsylvania Philadelphia, Pennsylvania | Nawar Latif, MD, MPH |
| University of Tennessee at Chattanooga Chattanooga, Tennessee | Stephen DePasquale, MD |
| University of Virginia Health Systems Charlottesville, Virginia | Linda Duska, MD |
| University of Wisconsin Madison, Wisconsin | Ellen Hartenbach, MD |
| Università Campus Bio-Medico di Roma Rome, Lazio | Roberto Angioli, MD |
| VCU Massey Cancer Center Richmond, Virginia | Leslie Randall, MD |
| Vardhan Mahavir Medical College and Safdarjung Hospital New Delhi, | Kaushal Kalra, Dr. |
| Virginia Cancer Specialists Arlington, Virginia | Robert Marsh, MD |
| Virginia Oncology Associates - Hampton Norfolk, Virginia | Michael McCollum |
| Vseobecna Fakultni Nemocnice v Praze Prague, | David Cibula |
| Western Pennsylvania Hospital Pittsburgh, Pennsylvania | Sarah Crafton |
| Willamette Valley Cancer Institute and Research Center Eugene, Oregon | Charles Anderson, MD |
| Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego SPZOZ w Lublinie Lublin, | Malgorzata Miacz, MD |
| Wojewodzki Szpital Specjalistyczny w Olsztynie Olsztyn, Warmia-Mazury | Magdalena Sikorska, MD |
| Women & Infants Hospital of Rhode Island Providence, Rhode Island | Elizabeth Lokich, MD - (lsegal@wihri.org) |
| Women's Cancer Associates St. Petersburg, Florida | Megan D Indermaur, MD Cheryl L Ryder, ARNP |
| Women's Cancer Care/Mary Bird Perkins Cancer Center Covington, Louisiana | Patricia Braly, MD |
| Womens Cancer Care Associates New York, New York | Joyce Barlin |
| Yale University School of Medicine New Haven, Connecticut | Alessandro Santin, MD |
| ZNA Middelheim Antwerp, | Dirk Schrijvers |
| Zala Megyei Szent Rafael Korhaz Zalaegerszeg, | Karoly Mahr, MD |
Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Gowda, Madhu, S
NCT00736749
HM12659
Show full eligibility criteria
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Inclusion Criteria:
* The patient must reside in the U.S. on the date of enrollment to ALTE05N1
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met PROCEDURE: Assessment of Therapy Complications, OTHER: Questionnaire Administration
Hematopoietic Cell Transplantation Recipient, Leukemia, Solid Tumor
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See this study on ClinicalTrials.gov
Show 164 locations
Study Locations
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| Location | Contacts |
|---|---|
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (dperry@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (melissa.leffin@orlandohealth.com) |
| Ascension Saint John Hospital Detroit, Michigan | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | |
| C S Mott Children's Hospital Ann Arbor, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Children's Healthcare of Atlanta - Egleston Atlanta, Georgia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Los Angeles Los Angeles, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Medical Center Of Akron Akron, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital New Orleans New Orleans, Louisiana | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (CancerAnswer@ccf.org) |
| Columbia Regional Columbia, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Floating Hospital for Children at Tufts Medical Center Boston, Massachusetts | |
| Florida Hospital Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Greenville Cancer Treatment Center Greenville, South Carolina | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Inova Fairfax Hospital Falls Church, Virginia | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Lee Memorial Health System Fort Myers, Florida | |
| Legacy Emanuel Children's Hospital Portland, Oregon | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (mamcdci@amedd.army.mil) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Mattel Children's Hospital UCLA Los Angeles, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Mayo Clinic Rochester, Minnesota | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Mercy Children's Hospital Toledo, Ohio | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | |
| Miami Cancer Institute Miami, Florida | Site Public Contact - (cancerinfo@baptisthealth.net) |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Mission Hospital Inc-Memorial Campus Asheville, North Carolina | Site Public Contact - (leslie.verner@msj.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (nr2616@cumc.columbia.edu) |
| NYU Winthrop Hospital Mineola, New York | |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Nemours Children's Clinic - Orlando Orlando, Florida | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | |
| Norton Children's Hospital Louisville, Kentucky | |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (nnechiporchik@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Gregory.Johnstone@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Overlook Hospital Summit, New Jersey | |
| Penn State Children's Hospital Hershey, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Primary Children's Hospital Salt Lake City, Utah | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Prisma Health Richland Hospital Columbia, South Carolina | |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rady Children's Hospital - San Diego San Diego, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Mountain States Tumor Institute Boise, Idaho | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Mary's Hospital Rhinelander, Wisconsin | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (Christy.Gilchrist@hshs.org) |
| Saint Vincent Hospital and Health Care Center Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| San Jorge Children's Hospital San Juan, | |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Sinai Hospital of Baltimore Baltimore, Maryland | Site Public Contact - (pridgely@lifebridgehealth.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| St. Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
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| T C Thompson Children's Hospital Chattanooga, Tennessee | |
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| The University of Arizona Medical Center-University Campus Tucson, Arizona | |
| Tulane University Health Sciences Center New Orleans, Louisiana | |
| UCSF Medical Center-Mission Bay San Francisco, California | |
| UCSF Medical Center-Parnassus San Francisco, California | |
| UF Cancer Center at Orlando Health Orlando, Florida | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (LByatt@nmcca.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | |
| Valley Children's Hospital Madera, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (mwellons@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial (INNOVATE)
Loney, Shenise - loneys2@vcu.edu
Urdaneta, Alfredo, I
NCT04134260
HM20021914
Show full eligibility criteria
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Inclusion Criteria:
* Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
* Any T-stage is eligible (American Joint Committee on Cancer \[AJCC\] 8th edition \[ed\])
* Appropriate stage for study entry based on fluciclovine F-18 PET scan (FACBC, Axumin) F-18 prostate-specific membrane antigen (PSMA) PET (PyLarify) scan, Gallium-68 PSMA PET scan, flotufolastat F-18 PSMA PET scan (Posluma), or C-11 or F-18 Choline PET within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease. For patients with PSA \< 0.20 ng/mL at time of registration, PET scan is recommended but not required
* Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen or nodal disease on imaging at time of recurrence (including external iliacs, internal iliacs, and/or obturator nodes); peri-prostatic and peri-rectal nodes can also be considered regional lymphadenopathy and are allowed
* History/physical examination within 90 days prior to registration
* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 90 days prior to registration
* Detectable PSA after radical prostatectomy. Detectable PSA is defined as serum PSA \> 0 ng/mL at least 30 days after prostatectomy
* Patients who have already started on post-prostatectomy GnRH agonist/antagonist for =\< 180 days prior to registration are eligible (Note: patients who started on an oral antiandrogen are eligible if started =\< 180 days and stopped prior to registration)
* Hemoglobin \>= 9.0 g/dL, independent of transfusion and/or growth factors (within 90 days prior to registration)
* Platelet count \>= 100,000 x 10\^9/uL independent of transfusion and/or growth factors (within 90 days prior to registration)
* Serum potassium \>= 3.5 mmol/L within 90 days prior to registration
* Creatinine clearance (CrCl) \>= 30 mL/min estimated by Cockcroft-Gault (please use actual weight for calculation unless greater than 30% above ideal body weight then use the adjusted body weight) (within 90 days prior to registration)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x ULN, subject is eligible) (within 90 days prior to registration)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (within 90 days prior to registration)
* Serum albumin \>= 3.0 g/dL (within 90 days prior to registration)
* Discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to registration
* The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count \>= 200 cells/microliter within 30 days prior to registration. Note: HIV testing is not required for eligibility for this protocol
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy within 30 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 30 days prior to registration
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ) who has no evidence of disease for \< 3 years must contact the principal investigator, Ronald Chen, Doctor of Medicine (MD)
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria:
* Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. Fluciclovine F-18 PET, \[FACBC, Axumin\], F-18 PSMA PET \[Pylarify\], flotufolastat F-18 PSMA PET scan \[Posluma\], Gallium-68 PSMA PET scan or C-11 choline PET)
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed (completed \> 3 years prior to registration)
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Androgen deprivation therapy (ADT) prior to radical prostatectomy
* Prior treatment with androgen receptor signaling inhibitor (including but not exclusive to a growing list of: abiraterone acetate, enzalutamide, apalutamide, darolutamide), unless started =\< 180 days and stopped prior to registration, which is allowed
* Current use of 5-alpha reductase inhibitor. NOTE: if the alpha reductase inhibitor is stopped prior to randomization the patient is eligible
* History of any of the following:
* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to registration, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy)
* Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 12 months prior to registration
* New York Heart Association functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification.)
* History of any condition that in the opinion of the investigator, would preclude participation in this study
* Current evidence of any of the following:
* Known gastrointestinal disorder affecting absorption of oral medications
* Active uncontrolled infection
* Presence of uncontrolled hypertension (persistent systolic blood pressure \[BP\] \>= 160 mmHg or diastolic BP \>= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment
* Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
* Baseline moderate and severe hepatic impairment (Child-Pugh Class B \& C)
* Inability to swallow oral pills
* Any current condition that in the opinion of the investigator, would preclude participation in this study
* Patients must not plan to participate in any other therapeutic clinical trials while receiving treatment on this study
* Patients with inflammatory bowel disease DRUG: Apalutamide, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, DRUG: Hormone Therapy, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy
Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
Prostate Cancer, Apalutamide, Abiraterone Acetate
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Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate High Tech Medical Park Palos Heights, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alton Memorial Hospital Alton, Illinois | |
| Altru Cancer Center Grand Forks, North Dakota | |
| Armes Family Cancer Center Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Audie L Murphy VA Hospital San Antonio, Texas | |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute - Mitchell Mitchell, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Pierre Pierre, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Bellin Memorial Hospital Green Bay, Wisconsin | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia | Site Public Contact - (Anne_caramella@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Brigham and Women's Hospital Boston, Massachusetts | |
| Broadlawns Medical Center Des Moines, Iowa | |
| CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Québec, Quebec | Site Public Contact - (rechclinique@crchuq.ulaval.ca) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Partners of Nebraska Lincoln, Nebraska | Site Public Contact - (research@cancerpartners.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carlisle Regional Cancer Center Carlisle, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Chester County Hospital West Chester, Pennsylvania | Site Public Contact - (carolann.hoppes@pennmedicine.upenn.edu) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Cleveland Clinic Akron General Akron, Ohio | Site Public Contact - (CancerAnswer@ccf.org) |
| Cleveland Clinic Cancer Center Mansfield Mansfield, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Cancer Center Strongsville Strongsville, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Wooster Family Health and Surgery Center Wooster, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Crozer Regional Cancer Center at Brinton Lake Glen Mills, Pennsylvania | |
| Crozer-Chester Medical Center Upland, Pennsylvania | |
| Crozer-Keystone Regional Cancer Center at Broomall Broomall, Pennsylvania | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware County Memorial Hospital Drexel Hill, Pennsylvania | |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duke Cancer Center Cary Cary, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| East Jefferson General Hospital Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory Decatur Hospital Decatur, Georgia | Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org) |
| Emory Johns Creek Hospital Johns Creek, Georgia | Site Public Contact - (m.lisa.hwang@emory.edu) |
| Emory Proton Therapy Center Atlanta, Georgia | Site Public Contact - (allyson.anderson@emory.edu) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Garnet Health Medical Center Middletown, New York | Site Public Contact - (jgerlach@garnethealth.org) |
| George Washington University Medical Center Washington D.C., District of Columbia | |
| Grady Health System Atlanta, Georgia | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Highland Hospital Rochester, New York | |
| Hillcrest Hospital Cancer Center Mayfield Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| IRMC Cancer Center Indiana, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Iowa Lutheran Hospital Des Moines, Iowa | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente South Bay Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente West Los Angeles Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Baldwin Park Baldwin Park, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Ontario Ontario, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Riverside Riverside, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Legacy Good Samaritan Hospital and Medical Center Portland, Oregon | |
| Legacy Mount Hood Medical Center Gresham, Oregon | |
| Legacy Salmon Creek Hospital Vancouver, Washington | |
| Los Angeles General Medical Center Los Angeles, California | |
| Loyola University Medical Center Maywood, Illinois | |
| MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey | |
| MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri | |
| Marin General Hospital Greenbrae, California | |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Mary Bird Perkins Cancer Center - Metairie Metairie, Louisiana | |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McLaren Cancer Institute-Flint Flint, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Macomb Mount Clemens, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Owosso Owosso, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Cancer Center - Carmichael Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Elk Grove Elk Grove, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Rocklin Rocklin, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Sacramento Sacramento, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Methodist West Hospital West Des Moines, Iowa | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Mid-Michigan Physicians-Lansing Lansing, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire | |
| North Coast Cancer Care Sandusky, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwell Health Physicians Partners Radiation Medicine at Queens Forest Hills, New York | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Francis Radiation Oncology at Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oncology Las Vegas - Henderson Henderson, Nevada | |
| Oncology Las Vegas - Tenaya Las Vegas, Nevada | |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Premier Blood and Cancer Center Dayton, Ohio | |
| Queens Cancer Center Rego Park, New York | |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridley-Tree Cancer Center Santa Barbara, California | |
| Robert Wood Johnson University Hospital Somerset Somerville, New Jersey | Site Public Contact - (Siby.Varughese@rwjbh.org) |
| Rush MD Anderson Cancer Center Chicago, Illinois | |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Rutgers New Jersey Medical School Newark, New Jersey | |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Luke's Hospital Chesterfield, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sands Cancer Center Canandaigua, New York | |
| Singh and Arora Hematology Oncology PC Flint, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Solinsky Center for Cancer Care Manchester, New Hampshire | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Tarrant County Hospital District/JPS Health Network Fort Worth, Texas | Site Public Contact - (macosta02@jpshealth.org) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Tibor Rubin VA Medical Center Long Beach, California | |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tulane University School of Medicine New Orleans, Louisiana | Site Public Contact - (bweimer1@tulane.edu) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California | |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UCSF Medical Center-Mount Zion San Francisco, California | |
| UCSF Medical Center-Parnassus San Francisco, California | |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Doral Doral, Florida | Site Public Contact - (kginnity@med.miami.edu) |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| UPMC Altoona Altoona, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center at UPMC McKeesport McKeesport, Pennsylvania | |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center in Coraopolis Moon Township, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Memorial York, Pennsylvania | |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC Uniontown Hospital Radiation Oncology Uniontown, Pennsylvania | |
| UPMC Washington Hospital Radiation Oncology Washington, Pennsylvania | Site Public Contact - (cancer@washingtonhospital.org) |
| UPMC-Heritage Valley Health System Beaver Beaver, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania | |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| UPMC-Shadyside Hospital Pittsburgh, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Unity Hospital Fridley, Minnesota | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Illinois Chicago, Illinois | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center at North Kansas City Hospital North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VCU Massey Cancer Center at Hanover Medical Park Mechanicsville, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Radiation Oncology Peru, Illinois | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| Wilmot Cancer Institute Radiation Oncology at Greece Rochester, New York | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
An Internet-based Program to Help Cancer Survivors Manage Pain (IMPACTS)
Karen Craver - NCORP@wakehealth.edu
Ameringer, Suzanne, W.
NCT04462302
HM20022887
Show full eligibility criteria
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Inclusion Criteria:
Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy (e.g. cytotoxic therapy, targeted therapy, immunotherapy, hormonal therapy, etc.). Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.
* May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer.
* Patients who currently undergoing anticancer therapy should not have any plans to change or adjust their treatment during the intervention period. This includes changing to another therapy or ending therapy entirely.
* Patients who are currently receiving anticancer therapy at the screening process must have been on current therapy for at least four weeks. Alternatively, if they are planning to discontinue therapy before enrolling, they must have been off therapy for four weeks prior to enrollment.
* A minimum of four weeks must have elapsed since the most recent MAJOR surgical intervention.
* A minimum of two weeks must have elapsed since the most recent MINOR surgical procedure (e.g., port placement).
* In addition, eligible patients must not have a planned surgical procedure or course of radiation therapy during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation-timepoint.
* Patients who are no longer receiving anticancer therapy must be less than/equal to 5 years since the completion of their anticancer therapy (e.g., time since the last day of chemotherapy administration, time since last day of radiotherapy, etc.).
* Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview.
* Must have a score of "Most Days" or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview.
* Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment. Eligible patients should not have planned upward dose titration of their analgesics during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation timepoint. Patients may elect to decrease their analgesic use during the study as per discussions with their provider. Unexpected dose adjustments including dose escalations as a result of unforeseen clinical need is allowed in all patients at all times during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context.
* Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment
* Must be expected to be able to complete all study activities including the 22- and 34-week follow-up assessments according to the treating/referring clinician (e.g., treating clinician feels the patient is unlikely to develop progressive disease requiring additional active cancer therapy through the 6-month follow-up period).
* ECOG performance status of 0, 1, or 2.
* Age ≥18 years at the time of study entry
* Must be able to speak, read and understand English.
Exclusion Criteria:
* Has a disability that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment, diagnosis or clinical evidence of severe psychiatric disorder, or diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.
* Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).
* Has a known or suspected diagnosable substance use disorder or opioid overuse disorder (according to DSM-5 criteria), or is actively receiving treatment for a substance use disorder, as per patient report or documented in the medical record.
* Currently being prescribed buprenorphine or suboxone.
* Patients enrolled on hospice care or end-of-life palliative care are not eligible for enrollment. Patients whose local care network provides an opportunity for palliative (symptom management) or supportive care concurrent with active treatment following diagnosis (i.e. not solely as a palliative or end-of-life measure) are considered eligible for this study.
* Does not have reliable access to Internet or sufficient personal data plan, and is not willing to participate in the Tablet Lending Program provided for this study.
* Does not have a working email address. BEHAVIORAL: Internet-based pain coping skills program
Cancer
Cancer pain, Survivor, Pain, Pain coping
I'm interested
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Show 150 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | - (mmcorc@healthpartners.com) |
| Broadlawns Medical Center Des Moines, Iowa | |
| CHRISTUS Highland Medical Center Shreveport, Louisiana | - (Nancy.hassan@christushealth.org) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (rhamrick@dmhhs.org) |
| Carle BroMenn Medical Center Normal, Illinois | - (Research@Carle.com) |
| Carle BroMenn Outpatient Center Bloomington, Illinois | - (Research@carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | - (Research@Carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | - (Research@Carle.com) |
| Carle on Vermilion Danville, Illinois | Site Public Contact - (Research@carle.com) |
| CentraState Medical Center Freehold, New Jersey | |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | - (aroland@kccop.org) |
| Chelsea Hospital Chelsea, Michigan | - (MCRCwebsitecontactform@stjoeshealth.org) |
| Chilton Medical Center Pompton, New Jersey | |
| Community Medical Center Missoula, Montana | - (HemonCCTrials@geisinger.edu) |
| Decatur Memorial Hospital Decatur, Illinois | - (morganthaler.jodi@mhsil.com) |
| FHP Health Center-Guam Tamuning, | |
| Fairview Southdale Hospital Edina, Minnesota | - (mmcorc@healthpartners.com) |
| Flaget Memorial Hospital Bardstown, Kentucky | - (ResearchInstituteInquiries@CommonSpirit.org) |
| Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania | - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center Danville, Pennsylvania | - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania | - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | - (HemonCCTrials@geisinger.edu) |
| Genesee Cancer and Blood Disease Treatment Center Flint, Michigan | - (wstrong@ghci.org) |
| Genesee Hematology Oncology PC Flint, Michigan | - (wstrong@ghci.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | - (wstrong@ghci.org) |
| Hackettstown Medical Center Hackettstown, New Jersey | |
| Hawaii Cancer Care - Savio ‘Aiea, Hawaii | |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Heartland Regional Medical Center Saint Joseph, Missouri | - (linda.schumacher@mymlc.com) |
| Illinois CancerCare - Washington Washington, Illinois | - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| John B. Amos Cancer Center Columbus, Georgia | - (cdean@iacthealth.com) |
| Kaiser Permanente Downtown Commons Sacramento, California | - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | - (Kpoct@kp.org) |
| Kaiser Permanente Medical Center-Vacaville Vacaville, California | - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | - (Kpoct@kp.org) |
| Kaiser Permanente- Marshall Medical Offices Redwood City, California | |
| Kaiser Permanente-Deer Valley Medical Center Antioch, California | - (Kpoct@kp.org) |
| Kaiser Permanente-Franklin Denver, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | - (Kpoct@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | - (Kpoct@kp.org) |
| Kaiser Permanente-Richmond Richmond, California | - (Kpoct@kp.org) |
| Kaiser Permanente-Rock Creek Lafayette, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | - (Kpoct@kp.org) |
| Kaiser Permanente-Stockton Stockton, California | - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Knox Community Hospital Mount Vernon, Ohio | - (sheree@columbusccop.org) |
| Lakeview Hospital Stillwater, Minnesota | - (mmcorc@healthpartners.com) |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | - (underberga@sjchs.org) |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Wausau Center Wausau, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Neillsville Neillsville, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center Dickinson Iron Mountain, Michigan | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | - (oncology.clinical.trials@marshfieldresearch.org) |
| Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital Chattanooga, Tennessee | - (Jeffh@columbusccop.org) |
| Mercy Hospital Coon Rapids, Minnesota | - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | - (cancerresearch@mercydesmoines.org) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Morristown Medical Center Morristown, New Jersey | |
| Newton Medical Center Newton, New Jersey | |
| North Memorial Medical Health Center Robbinsdale, Minnesota | - (mmcorc@healthpartners.com) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Ochsner Baptist Medical Center New Orleans, Louisiana | - (Elisemarie.curry@ochsner.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | - (Elisemarie.curry@ochsner.org) |
| Overlook Medical Center Summit, New Jersey | |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | - (mmcorc@healthpartners.com) |
| Peninsula Cancer Institute - Cancer Specialists of Tidewater Virginia Beach, Virginia | |
| Peninsula Cancer Institute - Gloucester Gloucester, Virginia | - (oramae.jackson@rivhs.com) |
| Peninsula Cancer Institute - Newport News Newport News, Virginia | - (oramae.jackson@rivhs.com) |
| Peninsula Cancer Institute - Williamsburg Williamsburg, Virginia | - (oramae.jackson@rivhs.com) |
| Physicians' Clinic of Iowa PC Cedar Rapids, Iowa | |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (kim.williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (kim.williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (kim.williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (kim.williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (kim.williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (kim.williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (kim.williams3@prismahealth.org) |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Regions Hospital Saint Paul, Minnesota | - (mmcorc@healthpartners.com) |
| Rice Memorial Hospital Willmar, Minnesota | - (mmcorc@healthpartners.com) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital East Lexington, Kentucky | - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph London London, Kentucky | - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph's/Candler - Bluffton Campus Bluffton, South Carolina | - (underberga@sjchs.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | - (kcovert@saintpetersuh.com) |
| Self Regional Healthcare Greenwood, South Carolina | - (nmcgaha@selfregional.org) |
| South Carolina Cancer Specialists PC Hilton Head Island, South Carolina | - (underberga@sjchs.org) |
| Southern Ohio Medical Center Portsmouth, Ohio | - (sheree@columbusccop.org) |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| The Cancer Center of Hawaii-Liliha Honolulu, Hawaii | |
| The Cancer Center of Hawaii-Pali Momi ‘Aiea, Hawaii | |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (sheree@columbusccop.org) |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | - (rohta@queens.org) |
| Tidelands Georgetown Memorial Hospital Georgetown, South Carolina | Site Public Contact - (broe@tidelandshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | |
| Trinity Health Medical Center - Canton Canton, Michigan | - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tripler Army Medical Center Honolulu, Hawaii | |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| VCU Community Memorial Health Center South Hill, Virginia | - (sherman.baker@vcuhealth.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | - (ctoclinops@vcu.edu) |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | - (CTOclinops@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Wake Forest University at Clemmons Clemmons, North Carolina | |
| Wake Forest University at Lexington Lexington, North Carolina |
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging (INDICATE)
Loney, Shenise - loneys2@vcu.edu
Urdaneta, Alfredo, I
NCT04423211
HM20021980
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Inclusion Criteria:
* STEP 0: REGISTRATION ELIGIBILITY CRITERIA
* Patient must be male and \>= 18 years of age.
* Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
* Patient must have biochemical recurrence (BCR) after RP, defined as follows:
* If time to BCR, defined as time to first detectable PSA ( \> lower limit of normal for assay used) after RP, is \< 12 months, a minimum PSA level of \>= 0.2 ng/mL and a confirmatory reading of \>= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible)
* If time to BCR, defined as time to first detectable PSA (\> lower limit of normal for assay used) after RP, is \>= 12 months, a minimum absolute PSA of 0.5 ng/mL is required
* If the patient has a detectable PSA (\> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement
* Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions
* Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration
* Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration
* Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.
* Patient must not be enrolled in another therapeutic clinical trial
* Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery
* Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI
* Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration
* Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy
* Hemoglobin (Hgb) \>= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)
* Leukocytes \>= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)
* Absolute neutrophil count \>= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration)
* Platelets \>= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)
* Total bilirubin \< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, must have a direct bilirubin of \< 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)
* Creatine \< 1.5 x instituional ULN (or measured creatinine clearance \> 30 mL/min)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)
* Patient must not have completed a course of prior pelvic radiation therapy for any reason
* Patient must agree not to father children while on study
* Patient must be English or Spanish speaking to be eligible for the QOL component of the study
* NOTE: Sites cannot translate the associated QOL forms
* STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA
* Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration
* For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)
* For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields \[prostate bed +/- typical whole pelvis\]), the number of extra-pelvic lesions must be known (1 - 5 or \> 5 extra-pelvic lesions) RADIATION: 3-Dimensional Conformal Radiation Therapy, DRUG: Apalutamide, PROCEDURE: Computed Tomography, DRUG: Degarelix, RADIATION: External Beam Radiation Therapy, OTHER: Fluciclovine F18, DRUG: Goserelin Acetate, PROCEDURE: Intensity-Modulated Proton Therapy, RADIATION: Intensity-Modulated Radiation Therapy, DRUG: Leuprolide Acetate, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, DRUG: Relugolix, RADIATION: Stereotactic Body Radiation Therapy, DRUG: Triptorelin, RADIATION: Volume Modulated Arc Therapy
Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
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Show 303 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Lakeside Hospital Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alton Memorial Hospital Alton, Illinois | |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Anchorage Oncology Centre Anchorage, Alaska | |
| Ascension Saint Mary's Hospital Saginaw, Michigan | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Ascension Saint Michael's Hospital Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Audie L Murphy VA Hospital San Antonio, Texas | |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bethesda North Hospital Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carlisle Regional Cancer Center Carlisle, Pennsylvania | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Garden City Garden City, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | Site Public Contact - (aroland@kccop.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Scott M. Glaser - (sglaser@coh.org) |
| City of Hope Corona Corona, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope South Pasadena South Pasadena, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| CoxHealth South Hospital Springfield, Missouri | |
| Creighton University Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Crozer Regional Cancer Center at Brinton Lake Glen Mills, Pennsylvania | |
| Crozer-Keystone Regional Cancer Center at Broomall Broomall, Pennsylvania | Site Public Contact - (Jolene.garney@crozer.org) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware County Memorial Hospital Drexel Hill, Pennsylvania | Site Public Contact - (jolene.garney@crozer.org) |
| Delbert Day Cancer Institute at PCRMC Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| ECU Health Oncology Kenansville Kenansville, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Kinston Kinston, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Richlands Richlands, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| FHCC South Lake Union Seattle, Washington | |
| FHCC at Northwest Hospital Seattle, Washington | |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fox Chase Cancer Center - East Norriton Hospital Outpatient Center East Norriton, Pennsylvania | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Fox Chase Cancer Center Buckingham Furlong, Pennsylvania | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Good Samaritan Regional Health Center Mount Vernon, Illinois | |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Health Partners Inc Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (linda.schumacher@mymlc.com) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Idaho Urologic Institute-Meridian Meridian, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Jewish Hospital Louisville, Kentucky | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Kalispell Regional Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver, Washington | |
| Legacy Good Samaritan Hospital and Medical Center Portland, Oregon | |
| Legacy Meridian Park Hospital Tualatin, Oregon | |
| Legacy Mount Hood Medical Center Gresham, Oregon | |
| Legacy Salmon Creek Hospital Vancouver, Washington | |
| Lenox Hill Hospital New York, New York | |
| Littleton Adventist Hospital Littleton, Colorado | |
| Longmont United Hospital Longmont, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Loyola University Medical Center Maywood, Illinois | |
| MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey | |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Maine Medical Center- Scarborough Campus Scarborough, Maine | |
| Maine Medical Center-Bramhall Campus Portland, Maine | |
| Maine Medical Partners - South Portland South Portland, Maine | |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| MaineHealth Coastal Cancer Treatment Center Bath, Maine | |
| MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford, Maine | |
| MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford, Maine | |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Marshfield Clinic-Minocqua Center Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Medical Center Modesto, California | Site Public Contact - (pallante.beth@mhsil.com) |
| Mercy Cancer Center Merced, California | |
| Mercy Cancer Center - Carmichael Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Elk Grove Elk Grove, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Rocklin Rocklin, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Sacramento Sacramento, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | Site Public Contact - (esmeralda.carrillo@mercy.net) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Union Square New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai West New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northwell Health Imbert Cancer Center Bay Shore, New York | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parker Adventist Hospital Parker, Colorado | |
| Parkland Health Center - Farmington Farmington, Missouri | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | |
| PeaceHealth Southwest Medical Center Vancouver, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth United General Medical Center Sedro-Woolley, Washington | Site Public Contact - (lkey@peacehealth.org) |
| Penn Presbyterian Medical Center Philadelphia, Pennsylvania | Site Public Contact - (PennCancerTrials@careboxhealth.com) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Phelps Memorial Hospital Center Sleepy Hollow, New York | |
| Porter Adventist Hospital Denver, Colorado | |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Cancer Institute Clackamas Clinic Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Regional Cancer Partnership Everett, Washington | Site Public Contact - (marilyn.birchman@providence.org) |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Centralia Centralia, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California | Site Public Contact - (Najee.Boucher@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Robert Wood Johnson University Hospital Somerset Somerville, New Jersey | Site Public Contact - (Siby.Varughese@rwjbh.org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Rush - Copley Medical Center Aurora, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush University Medical Center Chicago, Illinois | Site Public Contact - (clinical_trials@rush.edu) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Anthony Hospital Lakewood, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary Corwin Medical Center Pueblo, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Mary's Hospital Rhinelander, Wisconsin | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Saint Michael Cancer Center Silverdale, Washington | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | |
| Sibley Memorial Hospital Washington D.C., District of Columbia | Site Public Contact - (jquiver1@jhmi.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Skagit Regional Health Cancer Care Center Mount Vernon, Washington | Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org) |
| Southeast Cancer Center Cape Girardeau, Missouri | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Suburban Hospital Bethesda, Maryland | Site Public Contact - (bsquill1@jhmi.edu) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Ballard Campus Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Tarrant County Hospital District/JPS Health Network Fort Worth, Texas | Site Public Contact - (macosta02@jpshealth.org) |
| Temple University Hospital Philadelphia, Pennsylvania | |
| The Carle Foundation Hospital Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California | |
| UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland | |
| UPMC Altoona Altoona, Pennsylvania | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UPMC Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Center-Natrona Heights Natrona Heights, Pennsylvania | |
| UPMC Cancer Center-Uniontown Uniontown, Pennsylvania | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center in Coraopolis Moon Township, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Memorial York, Pennsylvania | |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC Susquehanna Williamsport, Pennsylvania | |
| UPMC Uniontown Hospital Radiation Oncology Uniontown, Pennsylvania | |
| UPMC Washington Hospital Radiation Oncology Washington, Pennsylvania | Site Public Contact - (cancer@washingtonhospital.org) |
| UPMC-Heritage Valley Health System Beaver Beaver, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania | |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| UPMC-Shadyside Hospital Pittsburgh, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern Simmons Cancer Center - RedBird Dallas, Texas | Site Public Contact - (canceranswerline@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Unity Hospital Fridley, Minnesota | |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | |
| University of Illinois Chicago, Illinois | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PennCancerTrials@careboxhealth.com) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| University of Wisconsin Carbone Cancer Center - Johnson Creek Johnson Creek, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Valley Radiation Oncology Peru, Illinois | |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Welch Cancer Center Sheridan, Wyoming | Site Public Contact - (mccinfo@mtcancer.org) |
| Westchester Medical Center Valhalla, New York | Site Public Contact - (ctsucontact@westat.com) |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| William S Middleton VA Medical Center Madison, Wisconsin | |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy
Katherine E. Reeder-Hayes, MD - kreeder@med.unc.edu
Thomson, Maria
NCT04379570
HM20022273
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* Women with an initial pathologically confirmed diagnosis of stage I-III, hormone receptor positive, HER2-neu negative, invasive breast cancer within 18 months prior to enrollment
* Women who have undergone neo-adjuvant chemotherapy who have no residual invasive disease post-surgery are eligible based on an initial pathologically confirmed diagnosis
* Hormone receptor positive is defined as estrogen receptor (ER) and/or progesterone receptor (PR) of \> 1%
* HER2-neu negative is defined as 0-1+ by immunohistochemical (IHC) analysis, or non-amplified by fluorescence in situ hybridization (FISH) analysis
* Patients must have received cancer-directed surgery, and/or completed all other adjuvant therapy, except reconstruction
* Patients must have initiated an endocrine therapy drug within the 6 months prior to registration, OR have received a prescription with stated intent to initiate within 6 weeks after registration
* No history of previous cancer as follows:
* Invasive or non-invasive breast cancer at any time
* Non-breast cancer, within the past 5 years, excluding non-melanoma skin cancer
* Patients must be willing to use a smart phone for study activities
* Patient is NOT to be deemed ineligible during the recruitment process if they do not have a smart phone
* If a participant does not own a smart phone or has limited data or texting capabilities or their smart phone cannot support the Alliance electronic patient reported outcomes (ePRO) survey application (app), a smart phone and service can be provided to the participant at no cost through the Ohio State University (OSU) partnership with Verizon Wireless for the duration of the study activities
* The CRP is ONLY to discuss this option with those patients who self-identify a phone-related barrier to participation, including: lack of a smart phone, insufficient phone plan (minutes/text/data), or a smart phone incompatible with the Alliance ePRO app
* For OSU -provided phones, charges will be paid by the grant through the intervention period. At the end of the 12-month intervention period, patients will be responsible for paying monthly fees, if continued service is desired. The physical phones will belong to the patients at the end of their study activities
* Patients must be willing to use a Pillsy medication event monitoring system for the duration of study participation
* In order to complete the mandatory patient-completed measures, participants must be able to speak and read English
OTHER: Educational Intervention, OTHER: Text Message-based Navigation Intervention, BEHAVIORAL: Motivational Interviewing, OTHER: Best Practice, OTHER: Questionnaire Administration, OTHER: Quality-of-Life Assessment
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2 Negative Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8
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Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Addison Gilbert Hospital Gloucester, Massachusetts | |
| AdventHealth Hendersonville Hendersonville, North Carolina | Site Public Contact - (AMBER.WHEELER@AdventHealth.com) |
| AdventHealth Infusion Center Asheville Asheville, North Carolina | Site Public Contact - (AMBER.WHEELER@AdventHealth.com) |
| AdventHealth Infusion Center Haywood Clyde, North Carolina | Site Public Contact - (AMBER.WHEELER@AdventHealth.com) |
| AdventHealth Infusion Center Weaverville Weaverville, North Carolina | Site Public Contact - (AMBER.WHEELER@AdventHealth.com) |
| Adventist Health Cancer Care Center Chico Chico, California | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | |
| AnMed Health Cancer Center Anderson, South Carolina | Site Public Contact - (rhonda.ballew@anmedhealth.org) |
| Arizona Center for Cancer Care - Gilbert Gilbert, Arizona | |
| Arizona Center for Cancer Care - Osborn Scottsdale, Arizona | |
| Arizona Center for Cancer Care - Phoenix Phoenix, Arizona | |
| Arizona Center for Cancer Care - Scottsdale Scottsdale, Arizona | |
| Arizona Center for Cancer Care-Peoria Peoria, Arizona | |
| Arizona Center for Cancer Care-Surprise Surprise, Arizona | |
| Armes Family Cancer Center Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Ascension All Saints Hospital Racine, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Borgess Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Ascension Calumet Hospital Chilton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Mercy Hospital Oshkosh, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Elizabeth Hospital Appleton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Via Christi Hospitals Wichita Wichita, Kansas | Site Public Contact - (research@viachristi.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | |
| Augusta Health Center for Cancer and Blood Disorders Fishersville, Virginia | |
| Aultman Alliance Community Hospital Alliance, Ohio | |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Ballad Health Cancer Care - Bristol Bristol, Virginia | Site Public Contact - (charles.mays@balladhealth.org) |
| Ballad Health Cancer Care - Kingsport Kingsport, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Ballad Health Cancer Care - Norton Norton, Virginia | Site Public Contact - (charles.mays@balladhealth.org) |
| Banner McKee Medical Center Loveland, Colorado | |
| Banner North Colorado Medical Center Greeley, Colorado | |
| Baptist Hospitals of Southeast Texas Cancer Center Beaumont, Texas | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care Winchester, Massachusetts | |
| Beverly Hospital Beverly, Massachusetts | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Billings Clinic-Cody Cody, Wyoming | |
| Blanchard Valley Hospital Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia | |
| Bon Secours DePaul Medical Center Norfolk, Virginia | |
| Bon Secours Health Center at Harbour View Suffolk, Virginia | |
| Bon Secours Maryview Medical Center Portsmouth, Virginia | |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bristol Regional Medical Center Bristol, Tennessee | |
| Broadlawns Medical Center Des Moines, Iowa | |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Broward Health North Deerfield Beach, Florida | |
| Bryn Mawr Hospital Bryn Mawr, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Cambridge Medical Center Cambridge, Minnesota | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center of Kansas - Chanute Chanute, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Dodge City Dodge City, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - El Dorado El Dorado, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - McPherson McPherson, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Newton Newton, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Parsons Parsons, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Pratt Pratt, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Salina Salina, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Wellington Wellington, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Wichita Wichita, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Winfield Winfield, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas-Independence Independence, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas-Kingman Kingman, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas-Liberal Liberal, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas-Manhattan Manhattan, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer Specialists of Tidewater Limited Chesapeake, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Cancer Specialists of Tidewater-Suffolk Suffolk, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| CaroMont Health - Lincoln Cancer Center Lincolnton, North Carolina | |
| CaroMont Regional Medical Center Gastonia, North Carolina | Site Public Contact - (tammy.cozad@caromonthealth.org) |
| CarolinaEast Medical Center New Bern, North Carolina | |
| CentraState Medical Center Freehold, New Jersey | |
| Centralia Oncology Clinic Centralia, Illinois | |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cookeville Regional Medical Center Cookeville, Tennessee | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas | |
| CoxHealth South Hospital Springfield, Missouri | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Danbury Hospital Danbury, Connecticut | |
| Dayton Physician LLC - Englewood Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC - Troy Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Atrium Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Miami Valley South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Wayne Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Decatur Memorial Hospital Decatur, Illinois | |
| Desert Regional Medical Center Palm Springs, California | |
| Doctor's Hospital of Laredo Laredo, Texas | |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| Englewood Hospital and Medical Center Englewood, New Jersey | |
| Enloe Medical Center Chico, California | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Fosston Fosston, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Jamestown Clinic Jamestown, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Park Rapids Park Rapids, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairbanks Memorial Hospital Fairbanks, Alaska | Site Public Contact - (Veronica.Stevenson@foundationhealth.org) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | |
| Fairview Ridges Hospital Burnsville, Minnesota | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Freeman Health System Joplin, Missouri | |
| Fremont - Rideout Cancer Center Marysville, California | |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California | |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Good Samaritan University Hospital West Islip, New York | |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Greater Dayton Cancer Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| HSHS Sacred Heart Hospital Eau Claire, Wisconsin | |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Health Partners Inc Minneapolis, Minnesota | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Associates of CNY at Camillus Camillus, New York | |
| Hematology Oncology Associates of Central New York-Auburn Auburn, New York | |
| Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York | |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Health Providence Novi Hospital Novi, Michigan | Site Public Contact - (kfife3@hfhs.org) |
| Henry Ford Health Providence Southfield Hospital Southfield, Michigan | Site Public Contact - (kfife3@hfhs.org) |
| Holy Name Hospital Teaneck, New Jersey | |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Clinic Livonia, Michigan | |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Idaho Urologic Institute-Meridian Meridian, Idaho | |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | |
| Illinois CancerCare-Macomb Macomb, Illinois | |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Inspira Medical Center Vineland Vineland, New Jersey | |
| Iowa Cancer Specialists Davenport, Iowa | Site Public Contact - (turnerk@genesishealth.com) |
| Iowa Lutheran Hospital Des Moines, Iowa | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Healthcare Port Townsend, Washington | |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Medical Center-Vacaville Vacaville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente South Bay Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente West Los Angeles Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Baldwin Park Baldwin Park, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Deer Valley Medical Center Antioch, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Franklin Denver, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Ontario Ontario, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Richmond Richmond, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Riverside Riverside, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Rock Creek Lafayette, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Stockton Stockton, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kent Hospital Warwick, Rhode Island | |
| Kettering Medical Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | |
| LSU Health Sciences Center at Shreveport Shreveport, Louisiana | |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lahey Medical Center-Peabody Peabody, Massachusetts | |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Lankenau Medical Center Wynnewood, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Luminis Health Anne Arundel Medical Center Annapolis, Maryland | |
| MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri | |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Maimonides Medical Center Brooklyn, New York | |
| Main Line Health Center-Collegeville Collegeville, Pennsylvania | |
| Main Line Health Center-Exton Exton, Pennsylvania | |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | Site Public Contact - (pardeecancerresearch@unchealth.unc.edu) |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | |
| Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin | |
| Marshfield Clinic-Wausau Center Wausau, Wisconsin | |
| Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin | |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | |
| Marshfield Medical Center - Weston Weston, Wisconsin | |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | |
| Mary Greeley Medical Center Ames, Iowa | |
| Mayo Clinic Health System in Albert Lea Albert Lea, Minnesota | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Hospital of Carbondale Carbondale, Illinois | |
| Memorial Hospital of Sweetwater County Rock Springs, Wyoming | Site Public Contact - (tharris@sweetwatermemorial.com) |
| Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri | |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Hospital Washington Washington, Missouri | |
| Mercy Medical Center Durango, Colorado | Site Public Contact - (acline@mdmercy.com) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| MercyOne Genesis Davenport Cancer Center Davenport, Iowa | |
| MercyOne Genesis Davenport Medical Center Davenport, Iowa | |
| MercyOne Genesis Silvis Cancer Center Silvis, Illinois | |
| Methodist Medical Center of Illinois Peoria, Illinois | |
| Methodist West Hospital West Des Moines, Iowa | |
| MetroHealth Medical Center Cleveland, Ohio | Site Public Contact - (ababal@metrohealth.org) |
| Miami Valley Hospital Dayton, Ohio | |
| Miami Valley Hospital North Dayton, Ohio | |
| Miami Valley Hospital South Centerville, Ohio | |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mountain Blue Cancer Care Center - Swedish Englewood, Colorado | |
| MultiCare Auburn Medical Center Auburn, Washington | Site Public Contact - (research@multicare.org) |
| MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane, Washington | Site Public Contact - (research@multicare.org) |
| MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane, Washington | Site Public Contact - (research@multicare.org) |
| MultiCare Gig Harbor Medical Park Gig Harbor, Washington | Site Public Contact - (research@multicare.org) |
| MultiCare Good Samaritan Hospital Puyallup, Washington | Site Public Contact - (research@multicare.org) |
| MultiCare Tacoma General Hospital Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Newland Medical Associates-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Newland Medical Associates-Pontiac Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northwest Hospital Center Randallstown, Maryland | Site Public Contact - (cancerinstitute@lifebridgehealth.org) |
| Norwalk Hospital Norwalk, Connecticut | Site Public Contact - (jennifer.long@norwalkhealth.org) |
| OSF Saint Anthony Medical Center Rockford, Illinois | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Orion Cancer Care Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Palo Alto Medical Foundation Health Care Palo Alto, California | |
| Palo Alto Medical Foundation-Camino Division Mountain View, California | |
| Palo Alto Medical Foundation-Fremont Fremont, California | |
| Palo Alto Medical Foundation-Santa Cruz Santa Cruz, California | |
| Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California | |
| Paoli Memorial Hospital Paoli, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Peninsula Cancer Institute-Cancer Specialists of Tidewater Virginia Beach, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Peninsula Cancer Institute-Gloucester Gloucester, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Peninsula Cancer Institute-Newport News Newport News, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Peninsula Cancer Institute-Williamsburg Williamsburg, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Penn Medicine Princeton Health Plainsboro, New Jersey | Site Public Contact - (PennCancerTrials@careboxhealth.com) |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Phoebe Putney Memorial Hospital Albany, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Phoenixville Hospital Phoenixville, Pennsylvania | |
| Physicians' Clinic of Iowa PC Cedar Rapids, Iowa | |
| Pottstown Hospital Pottstown, Pennsylvania | |
| Presbyterian Kaseman Hospital Albuquerque, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | |
| Prisma Health Greenville Memorial Hospital Greenville, South Carolina | |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| Providence Cancer Institute Clackamas Clinic Clackamas, Oregon | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Redeemer Health Meadowbrook, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riddle Memorial Hospital Media, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Aurora Aurora, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Boulder Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Littleton Littleton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Midtown Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Rose Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rush - Copley Medical Center Aurora, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| SSM Health Good Samaritan Mount Vernon, Illinois | |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint John's Cancer Institute Santa Monica, California | |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Warren Hospital Warren, Ohio | |
| Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri | |
| Saint Louis Cancer and Breast Institute-South City St Louis, Missouri | |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Cancer Center Worthington Worthington, Minnesota | |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Medical Center Fargo Fargo, North Dakota | |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford South University Medical Center Fargo, North Dakota | |
| Sanford Thief River Falls Medical Center Thief River Falls, Minnesota | |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sinai Hospital of Baltimore Baltimore, Maryland | Site Public Contact - (pridgely@lifebridgehealth.org) |
| Southeastern Medical Oncology Center-Clinton Clinton, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southern Ohio Medical Center Portsmouth, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Southpointe-Sanford Medical Center Fargo Fargo, North Dakota | |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | |
| Springfield Regional Cancer Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Springfield Regional Medical Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Summa Health Medina Medical Center Medina, Ohio | Site Public Contact - (cancerresearch@summahealth.org) |
| Summa Health System - Akron Campus Akron, Ohio | Site Public Contact - (cancerresearch@summahealth.org) |
| Summa Health System - Barberton Campus Barberton, Ohio | Site Public Contact - (cancerresearch@summahealth.org) |
| Summit Cancer Care-Memorial Savannah, Georgia | |
| Sutter Auburn Faith Hospital Auburn, California | |
| Sutter Medical Center Sacramento Sacramento, California | |
| Sutter Roseville Medical Center Roseville, California | |
| Tallahassee Memorial HealthCare Tallahassee, Florida | |
| The Carle Foundation Hospital Urbana, Illinois | |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.org) |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Medical Center Moline, Illinois | |
| Trinity Regional Medical Center Fort Dodge, Iowa | |
| UCSF Cancer Center - Berkeley Berkeley, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UCSF Cancer Center - San Mateo San Mateo, California | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland | |
| UM Saint Joseph Medical Center Towson, Maryland | Site Public Contact - (Jeanmarie.downing@umm.edu) |
| UM Upper Chesapeake Hematology and Oncology - Aberdeen Aberdeen, Maryland | Site Public Contact - (nfadrwoski@umm.edu) |
| UM Upper Chesapeake Medical Center Bel Air, Maryland | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UTMB Cancer Center at Victory Lakes League City, Texas | |
| UTMB Health Angleton Danbury Campus Angleton, Texas | |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Unity Hospital Fridley, Minnesota | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (tmyrick@uab.edu) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Texas Medical Branch Galveston, Texas | Site Public Contact - (clinical.research@utmb.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Upper Valley Medical Center Troy, Ohio | |
| Upstate Cancer Center at Verona Verona, New York | |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Valley Radiation Oncology Peru, Illinois | |
| Vassar Brothers Medical Center Poughkeepsie, New York | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Virginia Cancer Institute Richmond, Virginia | Site Public Contact - (smoore@vacancer.com) |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Virtua Samson Cancer Center Moorestown, New Jersey | Site Public Contact - (nctn@pennmedicine.upenn.edu) |
| Virtua Voorhees Voorhees Township, New Jersey | Site Public Contact - (nctn@pennmedicine.upenn.edu) |
| Walter Knox Memorial Hospital Emmett, Idaho | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Waverly Hematology Oncology Cary, North Carolina | |
| Wayne Hospital Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Welch Cancer Center Sheridan, Wyoming | |
| Wellmont Holston Valley Hospital and Medical Center Kingsport, Tennessee | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Suburban Medical Center River Forest, Illinois | |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| William E Kahlert Regional Cancer Center/Sinai Hospital Westminster, Maryland | |
| Women and Infants Hospital Providence, Rhode Island | |
| Zuckerberg San Francisco General Hospital San Francisco, California |
Cardiac Outcomes With Near-Complete Estrogen Deprivation (CROWN)
Sarah Hatcher, MPH - sarah.hatcher@duke.edu
Jordan, Jennifer
NCT05309655
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Inclusion Criteria
* Women age ≤55 who were premenopausal at the time of breast cancer diagnosis; (Premenopausal is defined as per NCCN criteria).
* Planned breast cancer treatment with NCED (near-complete estrogen deprivation) therapy that includes aromatase inhibitor therapy (or SERD) with medically or surgically induced menopause within three (3) months of initiating NCED (HR-positive tumor) or, for the cohorts not receiving NCED therapy, within three (3) months of planned chemotherapy, surgery or radiation. Index date for three months is defined as final date of treatment with chemotherapy, surgery or radiation which ever happens last (HR-negative tumor). Treatment with a Gonadotropin Releasing Hormone (GnRH) agonist for fertility preservation during chemotherapy is allowed and is not considered part of the NCED antineoplastic therapy.
* Women with human epidermal growth factor-2 (HER2) negative and women with human epidermal growth factor-2 (HER2) positive breast cancer are eligible.
* Treatment with CDK-inhibitor, PARP inhibitor immunotherapy or biologic (non-chemotherapy) agent as part of anti-neoplastic treatment plan is allowed. These agents are not considered chemotherapy.
* Treatment with selective-estrogen receptor degrader (SERD) rather than aromatase inhibitor is allowed.
* Diagnosed with Stage I-III breast cancer.
* ECOG performance status of 0-2
* Patients with concurrent malignancies are eligible as long as therapies and disease course for these are reasonably expected to not impact cardiovascular function. (Examples of eligible malignancies include: papillary/follicular thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in-situ and early stage cervical cancers, etc.).
* Patients with prior COVID-19 are eligible if they have recovered from the illness and are free of COVID-related symptoms other than allowable persistent symptoms: loss of taste and smell and/or grade 1 fatigue.
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
* The study will allow up to 30% of patients with MRI non-compatible breast expanders recognizing that baseline CMR will be outside of imaging window. Note: Registration of these participants will require study PI approval (Dr. Jordan or Dr. Thomas).
Exclusion Criteria:
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to adenosine
* Active wheezing.
* Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices, or some breast expanders.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study. Because some methods of birth control are not 100% reliable, a pregnancy test is required, unless the patient has undergone either a bilateral oophorectomy, hysterectomy or both.
* Coronary revascularization in the past 6 months or known severe multi-vessel coronary artery disease previously determined to be not amendable to mechanical intervention.
* Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization
* Allergy or prior sensitivity to gadolinium or other contrasting agents or their excipients.
* Men with breast cancer.
* Known chronic renal insufficiency or chronic electrolyte abnormalities as determined by the treating physician. DRUG: Adenosine Stress Cardiac Magnetic Resonance Imaging, DIAGNOSTIC_TEST: Electrocardiogram, DIAGNOSTIC_TEST: Computed Tomography Angiogram, OTHER: Laboratory Testing, BEHAVIORAL: Quality of Life Survey
Breast Cancer, Triple Negative Breast Cancer, Cardiovascular Complications
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Study Locations
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| Location | Contacts |
|---|---|
| Duke Cancer Center Durham, North Carolina | Sarah Hatcher, MPH - (sarah.hatcher@duke.edu) |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia | Nicole Kaopua - (Kaopuakn@vcu.edu) |
| Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina | Sarah Hatcher, MPH - (sarah.hatcher@duke.edu) |
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma (ENVASARC)
Charles Theuer, MD, PhD - clinicaltrials@traconpharma.com
Poklepovic, Andrew, S
NCT04480502
HM20023448
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Inclusion Criteria:
• Histologically confirmed locally advanced or metastatic undifferentiated pleomorphic sarcoma (UPS) or grade ≥ 2 myxofibrosarcoma (MFS)
• Documented progression following systemic chemotherapy
• At least one measurable lesion
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Adequate hematologic and organ function
Exclusion Criteria:
• More than two prior lines of chemotherapy for UPS/MFS
• Prior immune checkpoint inhibitor or immunomodulatory therapy
• Active autoimmune disease that has required systemic treatment
• Major surgery within 4 weeks of dosing of investigational agent
• Active additional malignancy
• Pericardial effusion, pleural effusion, or ascites
• Central nervous system metastases and/or carcinomatous meningitis
• Active hepatitis or cirrhosis
• Interstitial lung disease
• Unwilling to apply highly effective contraception during the study
• Other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study
Biological: Envafolimab, Drug: Ipilimumab
Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma
sarcoma
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Study Locations
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| Location | Contacts |
|---|---|
| Cleveland Clinic Cleveland, Ohio | |
| Columbia University New York, New York | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Duke University Durham, North Carolina | |
| H. Lee Moffitt Cancer Center Tampa, Florida | |
| Huntsman Cancer Institute Salt Lake City, Utah | |
| Johns Hopkins University Baltimore, Maryland | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Mayo Clinic, Jacksonville Jacksonville, Florida | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Northwestern University Chicago, Illinois | |
| Ohio State University Columbus, Ohio | |
| Royal Marsden London, | |
| Sarcoma Oncology Research Center Santa Monica, California | |
| Seattle Cancer Care Alliance Seattle, Washington | |
| Stanford University Palo Alto, California | |
| Thomas Jefferson University (Sidney Kimmel Cancer Center) Philadelphia, Pennsylvania | |
| University Hospitals Cleveland, Ohio | |
| University of Arizona Tucson, Arizona | |
| University of California, Los Angeles Los Angeles, California | |
| University of Colorado Aurora, Colorado | |
| University of Miami Miami, Florida | |
| University of Michigan Ann Arbor, Michigan | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Pittsburgh Pittsburgh, Pennsylvania | |
| Vanderbilt University Nashville, Tennessee | |
| Virginia Commonwealth University Richmond, Virginia | |
| Washington University in St. Louis St Louis, Missouri |