Combination Chemotherapy with or without Temsirolimus in Treating Patients with Intermediate Risk Rhabdomyosarcoma

Status: Active

Description

This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy or combination chemotherapy plus temsirolimus is more effective in treating patients with intermediate-risk rhabdomyosarcoma.

Eligibility Criteria

Inclusion Criteria

  • Feasibility Phase: Patients must be < 21 years of age at the time of enrollment; please note: the feasibility phase is complete, effective with amendment #1
  • Efficacy Phase: Patients must be =< 40 years of age at the time of enrollment
  • Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon stage, group, and age, as below
  • RMS types included under embryonal rhabdomyosarcoma (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2013 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant); classification of alveolar rhabdomyosarcoma (ARMS) in the 2013 WHO classification is the same as in the ICR and includes classic and solid variants * ERMS ** Stage 1, group III (non-orbit) ** Stage 3, group I/II ** Stage 2/3, group III ** Stage 4, group IV, < 10 years old * ARMS: ** Stages 1-3, groups I-III
  • Specimen Submission: Patients must have sufficient tissue available for the required biology study
  • Lansky performance status score >= 50 for patients =< 16 years of age; Karnofsky performance status score >= 50 for patients > 16 years of age
  • Peripheral absolute neutrophil count (ANC) >= 750/uL
  • Platelet count >= 75,000/uL
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows: * 1 month to < 6 months old: 0.4 mg/dl (male), 0.4 mg/dl (female) * 6 months to < 1 year old: 0.5 mg/dl (male), 0.5 mg/dl (female) * 1 to < 2 years old: 0.6 mg/dl (male), 0.6 mg/dl (female) * 2 to < 6 years old: 0.8 mg/dl (male), 0.8 mg/dl (female) * 6 to < 10 years old: 1 mg/dl (male), 1 mg/dl (female) * 10 to < 13 years old: 1.2 mg/dl (male), 1.2 mg/dl (female) * 13 to < 16 years old: 1.5 mg/dl (male), 1.4 mg/dl (female) * >= 16 years old: 1.7 mg/dl (male), 1.4 mg/dl (female) * Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible; however, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (i.e. percutaneous nephrostomies or ureteric stents) of the urinary tract
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • 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 who have previously received temsirolimus, another mTOR inhibitor, or any other investigational agent
  • Patients who have received any chemotherapy (excluding steroids) and/or RT prior to this enrollment
  • Patients with uncontrolled hyperglycemia
  • Patients with uncontrolled hyperlipidemia
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for at least 3 months after treatment is completed
  • Female patients who are pregnant are not eligible; Note: a pregnancy test is required for female patients of childbearing potential prior to study entry
  • Lactating females who plan to breastfeed their infants are not eligible

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Mobile
USA Health Strada Patient Care Center
Status: Active
Contact: Site Public Contact
Phone: 800-388-8721

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Oncology and Hematology LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Anchorage Associates in Radiation Medicine
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Oncology Centre
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Radiation Therapy Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Mesa
Cardon Children's Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Phoenix
Mayo Clinic Hospital
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Phoenix Childrens Hospital
Status: Active
Contact: Site Public Contact
Phone: 602-546-0920
Scottsdale
Mayo Clinic in Arizona
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Tucson
The University of Arizona Medical Center-University Campus
Status: Active
Contact: Site Public Contact
Phone: 520-626-9008

Arkansas

Little Rock
Arkansas Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

California

Anaheim
Kaiser Permanente-Anaheim
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Arroyo Grande
PCR Oncology
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Bellflower
Kaiser Permanente-Bellflower
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 818-847-4793
Email: Najee.Boucher@providence.org
Downey
Kaiser Permanente Downey Medical Center
Status: Active
Contact: Site Public Contact
Phone: 510-891-3400
Fontana
Kaiser Permanente-Fontana
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 909-558-3375
Los Angeles
Children's Hospital Los Angeles
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Kaiser Permanente Los Angeles Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Mattel Children's Hospital UCLA
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
UCLA / Jonsson Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-798-0719
Madera
Valley Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Kaiser Permanente-Oakland
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Children's Hospital of Orange County
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
San Diego
Kaiser Permanente-San Diego Mission
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Naval Medical Center -San Diego
Status: Active
Contact: Site Public Contact
Phone: 619-532-8712
Rady Children's Hospital - San Diego
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
San Francisco
UCSF Medical Center-Mission Bay
Status: Active
Contact: Site Public Contact
Phone: 877-827-3222
Torrance
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Status: Active
Contact: Site Public Contact
Phone: 310-222-3621

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
Yale University
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 302-651-6884
Email: dperry@nemours.org

District of Columbia

Washington
Children's National Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Kaiser Permanente-Capitol Hill Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 301-548-5743
Sibley Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 202-243-2373
Email: jquiver1@jhmi.edu

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: Site Public Contact
Phone: 352-273-8010
Email: cancer-center@ufl.edu
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Miami
Nicklaus Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 321-843-2584
Email: melissa.leffin@orlandohealth.com
Florida Hospital Orlando
Status: Active
Contact: Site Public Contact
Phone: 407-303-2090
Email: FH.Cancer.Research@flhosp.org
Nemours Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Tampa General Hospital
Status: Active
Contact: Site Public Contact
Phone: 813-844-7829
Email: syapchanyk@tgh.org
West Palm Beach
Saint Mary's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Augusta
Augusta University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 706-721-2388
Email: ga_cares@augusta.edu
Savannah
Memorial Health University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 912-350-7887
Email: clayter1@memorialhealth.com

Hawaii

Honolulu
Kaiser Permanente Moanalua Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 808-432-5195
Email: shelley.a.clark@kp.org
Kapiolani Medical Center for Women and Children
Status: Active
Contact: Site Public Contact
Phone: 808-983-6090
Straub Clinic and Hospital
Status: Active
Contact: Site Public Contact
Phone: 808-522-4333

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-864-5204
Lurie Children's Hospital-Chicago
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Rush University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Peoria
Saint Jude Midwest Affiliate
Status: Active
Contact: Site Public Contact
Phone: 888-226-4343
Springfield
Memorial Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-788-3528
Saint John's Hospital
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Southern Illinois University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Site Public Contact
Phone: 317-338-2194
Email: research@stvincent.org

Iowa

Des Moines
Blank Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Iowa Lutheran Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 515-241-6727
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Louisiana

New Orleans
Children's Hospital New Orleans
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org

Maine

Bangor
Eastern Maine Medical Center
Status: Active
Contact: Site Public Contact
Phone: 207-973-4274
Scarborough
Maine Children's Cancer Program
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-888-8823

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 877-442-3324
Floating Hospital for Children at Tufts Medical Center
Status: Active
Contact: Site Public Contact
Phone: 617-636-5535
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-726-5130
Worcester
University of Massachusetts Medical School
Status: Active
Contact: Site Public Contact
Phone: 508-856-3216
Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Battle Creek
Bronson Battle Creek
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Detroit
Ascension Saint John Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
East Lansing
Michigan State University Clinical Center
Status: Active
Contact: Site Public Contact
Phone: 517-975-9547
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Mercy Health Saint Mary's
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
Borgess Medical Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Bronson Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Muskegon
Mercy Health Mercy Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Niles
Lakeland Hospital Niles
Status: Active
Contact: Site Public Contact
Phone: 269-556-2880
Email: crcwm-regulatory@crcwm.org
Port Huron
Huron Medical Center PC
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Lake Huron Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Reed City
Spectrum Health Reed City Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: Active
Contact: Site Public Contact
Phone: 248-551-0360
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: Active
Contact: Site Public Contact
Phone: 800-865-7884
Email: crcwm-regulatory@crcwm.org
Marie Yeager Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Traverse City
Munson Medical Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Wyoming
Metro Health Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University of Minnesota / Masonic Cancer Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Columbia
Columbia Regional
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Kansas City
Children's Mercy Hospitals and Clinics
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Saint Louis
Barnes-Jewish Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@ccadmin.wustl.edu
Cardinal Glennon Children's Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-7066
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu

Montana

Missoula
Saint Patrick Hospital - Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-327-3118
Email: amy.hanneman@providence.org

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University of Nebraska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu

Nevada

Carson City
Carson Tahoe Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Henderson
21st Century Oncology-Henderson
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Cancer and Blood Specialists-Henderson
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Henderson
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Las Vegas Cancer Center-Henderson
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at Seven Hills
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Las Vegas
21st Century Oncology
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
21st Century Oncology-Fort Apache
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
21st Century Oncology-Vegas Tenaya
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Ann M Wierman MD LTD
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Cancer and Blood Specialists-Shadow
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Cancer and Blood Specialists-Tenaya
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Cancer Therapy and Integrative Medicine
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Central Valley
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Northwest
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada-Summerlin
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Desert West Surgery
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
HealthCare Partners Medical Group Oncology / Hematology-Centennial Hills
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
HealthCare Partners Medical Group Oncology / Hematology-Maryland Parkway
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
HealthCare Partners Medical Group Oncology / Hematology-San Martin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
HealthCare Partners Medical Group Oncology / Hematology-Tenaya
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Las Vegas Cancer Center-Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at Fort Apache
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at MountainView
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at Oakey
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Radiation Oncology Centers of Nevada Central
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Radiation Oncology Centers of Nevada Southeast
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Summerlin Hospital Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Sunrise Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
University Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
University Medical Center of Southern Nevada
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Reno
Radiation Oncology Associates
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Renown Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Saint Mary's Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: Active
Contact: Site Public Contact
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Site Public Contact
Phone: 732-235-8675
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Active
Contact: Site Public Contact
Phone: 732-235-8675
Saint Peter's University Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Newark
Newark Beth Israel Medical Center
Status: Active
Contact: Site Public Contact
Phone: 973-926-7230
Paterson
Saint Joseph's Regional Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

New York

Albany
Albany Medical Center
Status: Active
Contact: Site Public Contact
Phone: 518-262-5513
Bronx
Children's Hospital at Montefiore
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Weiler Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
Mineola
NYU Winthrop Hospital
Status: Active
Contact: Site Public Contact
Phone: 866-946-8476
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Site Public Contact
Phone: 212-263-4434
Email: prmc.coordinator@nyumc.org
Mount Sinai Hospital
Status: Active
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-305-6361
Email: nr2616@cumc.columbia.edu
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476
Valhalla
New York Medical College
Status: Active
Contact: Site Public Contact
Phone: 914-594-3794
Westchester Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com

North Carolina

Asheville
Mission Hospital Inc-Memorial Campus
Status: Active
Contact: Site Public Contact
Phone: 828-213-4150
Email: leslie.verner@msj.org
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolina Surgical Clinic of Charlotte PA
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-8920
Email: nnechiporchik@novanthealth.org
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Novant Health Presbyterian Medical Center
Status: Active
Contact: Site Public Contact
Phone: 704-384-5369
Email: nnechiporchik@novanthealth.org
Oncology Specialists of Charlotte
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-8920
Email: nnechiporchik@novanthealth.org
Southern Oncology Specialists-Charlotte
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-8920
Email: nnechiporchik@novanthealth.org
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853
Greenville
East Carolina University
Status: Active
Contact: Site Public Contact
Phone: 252-744-1015
Email: eubankss@ecu.edu
Huntersville
Lake Norman Hematology Oncology Specialists-Huntersville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-8920
Email: nnechiporchik@novanthealth.org
Novant Health Presbyterian Medical Center Huntersville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-5369
Email: nnechiporchik@novanthealth.org
Southern Oncology Specialists-Huntersville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-8920
Email: nnechiporchik@novanthealth.org
Matthews
Matthews Radiation Oncology Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-8920
Email: nnechiporchik@novanthealth.org
Novant Health Cancer Specialists-Matthews
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-8920
Email: nnechiporchik@novanthealth.org
Mooresville
Lake Norman Hematology Oncology Specialists-Mooresville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-8920
Email: nnechiporchik@novanthealth.org
Lake Norman Radiation Oncology Center-Mooresville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-8920
Email: nnechiporchik@novanthealth.org
Salisbury
Carolina Oncology Associates PA
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-636-5542
Email: nnechiporchik@novanthealth.org
Rowan Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-210-5000
Email: nnechiporchik@novanthealth.org
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Cleveland
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Rainbow Babies and Childrens Hospital
Status: Active
Contact: Site Public Contact
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Dayton
Dayton Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Sylvania
ProMedica Flower Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842
Toledo
The Toledo Hospital / Toledo Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Bend
Saint Charles Health System
Status: Active
Contact: Site Public Contact
Phone: 541-706-2909
Email: nosall@stcharleshealthcare.org
Clackamas
Clackamas Radiation Oncology Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Oncology and Hematology Care Southeast
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Coos Bay
Bay Area Hospital
Status: Active
Contact: Site Public Contact
Phone: 541-269-8392
Email: cherie.cox@bayareahospital.org
Newberg
Providence Newberg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Portland
Legacy Emanuel Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Oregon Health and Science University
Status: Active
Contact: Site Public Contact
Phone: 503-494-1080
Email: trials@ohsu.edu
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Hershey
Penn State Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Saint Christopher's Hospital for Children
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Puerto Rico

Caguas
HIMA San Pablo Oncologic Hospital
Status: Active
Contact: Site Public Contact
Phone: 787-653-3434
San Juan
San Jorge Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University Pediatric Hospital
Status: Active
Contact: Site Public Contact
Phone: 787-474-0333

Rhode Island

Providence
Rhode Island Hospital
Status: Active
Contact: Site Public Contact
Phone: 401-444-1488

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
Columbia
Prisma Health Richland Hospital
Status: Active
Contact: Site Public Contact
Phone: 803-434-3533
Greenville
BI-LO Charities Children's Cancer Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Chattanooga
T C Thompson Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Knoxville
East Tennessee Childrens Hospital
Status: Active
Contact: Site Public Contact
Phone: 865-541-8266
Nashville
The Children's Hospital at TriStar Centennial
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Corpus Christi
Driscoll Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Dallas
Medical City Dallas Hospital
Status: Active
Contact: Site Public Contact
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
El Paso
El Paso Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 713-798-1354
Email: burton@bcm.edu
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-312-3961
Lubbock
Covenant Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
San Antonio
Children's Hospital of San Antonio
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Methodist Children's Hospital of South Texas
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University Hospital
Status: Active
Contact: Site Public Contact
Phone: 210-358-4176
Email: evelyn.swenson-britt@uhs-sa.com
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Site Public Contact
Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu
Temple
Scott and White Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 254-724-5407

Utah

Salt Lake City
Primary Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Vermont

Burlington
University of Vermont and State Agricultural College
Status: Active
Contact: Site Public Contact
Phone: 802-656-8990
Email: rpo@uvm.edu

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 434-243-6303
Email: PAS9E@virginia.edu
Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Site Public Contact
Phone: 703-208-6650
Email: Stephanie.VanBebber@inova.org
Norfolk
Children's Hospital of The King's Daughters
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Portsmouth
Naval Medical Center - Portsmouth
Status: Active
Contact: Site Public Contact
Phone: 757-953-5939

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-715-4133
Email: mjohnson9@peacehealth.org
Centralia
Providence Regional Cancer System-Centralia
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Edmonds
Swedish Cancer Institute-Edmonds
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Everett
Providence Regional Cancer Partnership
Status: Active
Contact: Site Public Contact
Phone: 425-261-3529
Email: marilyn.birchman@providence.org
Issaquah
Swedish Cancer Institute-Issaquah
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Kennewick
Kadlec Clinic Hematology and Oncology
Status: Active
Contact: Site Public Contact
Phone: 509-783-4637
Email: research@kadlecmed.org
Lacey
Providence Regional Cancer System-Lacey
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Longview
PeaceHealth Saint John Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-2016
Email: kmakin-bond@peacehealth.org
Seattle
Pacific Gynecology Specialists
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Seattle Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Swedish Medical Center-Ballard Campus
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Cherry Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-First Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
University of Washington Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-804-8824
Shelton
Providence Regional Cancer System-Shelton
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Rockwood Cancer Treatment Center-DHEC-Downtown
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Rockwood North Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Spokane Valley
Rockwood Clinic Cancer Treatment Center-Valley
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Tacoma
Madigan Army Medical Center
Status: Active
Contact: Site Public Contact
Phone: 253-968-0129
Email: mamcdci@amedd.army.mil
Mary Bridge Children's Hospital and Health Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Vancouver
PeaceHealth Southwest Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-3940
Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 509-897-5993
Email: Cheryl.Dodd@providence.org
Yelm
Providence Regional Cancer System-Yelm
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org

West Virginia

Bridgeport
United Hospital Center
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu
Martinsburg
WVUH-Berkely Medical Center
Status: Active
Contact: Site Public Contact
Phone: 304-260-1477
Email: cancertrialsinfo@hsc.wvu.edu
Morgantown
West Virginia University Healthcare
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu
Parkersburg
Camden Clark Medical Center
Status: Active
Contact: Site Public Contact
Phone: 304-424-2585
Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Medical Center-Marshfield
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Children's Hospital of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-955-4727
Email: MACCCTO@mcw.edu

British Columbia

Vancouver
British Columbia Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Manitoba

Winnipeg
CancerCare Manitoba
Status: Active
Contact: Site Public Contact
Phone: 866-561-1026
Email: ctu_web@cancercare.mb.ca

Newfoundland and Labrador

Saint John's
Janeway Child Health Centre
Status: Active
Contact: Site Public Contact
Phone: 866-722-1126

Nova Scotia

Halifax
IWK Health Centre
Status: Active
Contact: Site Public Contact
Phone: 902-470-6767

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Kingston
Kingston Health Sciences Centre
Status: Active
Contact: Site Public Contact
Phone: 613-549-6666
Email: cc-clinicaltrials@kgh.kari.net
London
Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Ottawa
Children's Hospital of Eastern Ontario
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Toronto
Hospital for Sick Children
Status: Active
Contact: Site Public Contact
Phone: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: Active
Contact: Site Public Contact
Phone: 514-345-4931
The Montreal Children's Hospital of the MUHC
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Quebec
Centre Hospitalier Universitaire de Quebec
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Saskatchewan

Saskatoon
Saskatoon Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 306-655-2914

Australia

Hunter Regional Mail Centre
John Hunter Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Perth
Perth Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Randwick
Sydney Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
South Brisbane
Queensland Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Westmead
The Children's Hospital at Westmead
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

New Zealand

Christchurch
Christchurch Hospital
Status: Active
Contact: Site Public Contact
Phone: 03 364 0640
Grafton
Starship Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare the event-free survival (EFS) of patients with intermediate-risk (IR) rhabdomyosarcoma (RMS) treated with surgery, radiotherapy, and vincristine (vincristine sulfate), dactinomycin, and cyclophosphamide (VAC) alternating with vincristine and irinotecan (irinotecan hydrochloride) (VI) (VAC/VI) with maintenance to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus with maintenance.

SECONDARY OBJECTIVES:

I. To compare the overall survival (OS) of patients with IR RMS treated with surgery, radiotherapy, and VAC alternating with VI with maintenance to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus with maintenance.

EXPLORATORY OBJECTIVES:

I. To compare the outcome of patients based on their forkhead box O1 protein (FOXO1) fusion gene partner, by evaluating paired box (PAX) 3 versus (vs) PAX7 in all patients found to be FOXO1 fusion positive.

II. To compare the outcome of patients based on their [F18]-fluorodeoxy-D-glucose-positron emission tomography (FDG-PET) response at week 9 (positive or negative), as assessed by Deauville criteria (5-point).

III. To estimate the frequency of patients with circulating tumor deoxyribonucleic acid (DNA) (ctDNA) at diagnosis and subsequent time-points.

IV. To compare the outcome of patients (VAC/VI with or without temsirolimus) who have received maintenance therapy on ARST1431 to those who received VAC/VI on ARST0531.

OUTLINE:

FEASIBILITY PHASE (THE FEASIBILITY PHASE IS COMPLETE, EFFECTIVE WITH AMENDMENT #1A): (< 21 years old): This is a dose-escalation study of temsirolimus.

Patients receive vincristine sulfate intravenously (IV) over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37, and temsirolimus IV over 30-60 minutes on days 1, 8, and 15. Patients also undergo radiation therapy (RT) beginning week 13 for up to 6.5 weeks. Courses with temsirolimus repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity.

EFFICACY PHASE: Patients are randomized to Regimen A or B. Patients with disease that is ARMS FOXO1 fusion negative (stage I, group I/II, stage 1, group III [orbit] or stage II, group I/II) are assigned to Regimen C.

REGIMEN A (VAC/VI): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) once daily (QD) on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.

REGIMEN B (VAC/VI TEMSIROLIMUS): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE (Patients in Regimen A or Regimen B): Patients receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 6 cycles.

REGIMEN C (FOXO1 FUSION NEGATIVE): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually for up to 10 years.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
Abha Anshu Gupta

Trial IDs

Primary ID ARST1431
Secondary IDs NCI-2015-01644
Clinicaltrials.gov ID NCT02567435