Clinical Trial - NCT02567435

Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma

Recruiting

Sponsor: National Cancer Institute (NCI)

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02567435

Protocol Info

Short Description: ARST1431: Phase III of VAC - VAC/VI + Temsirolimus in Intermediate Risk Rhabdomyosarcoma (RMS)
Long Description: ARST1431: A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)
MGH Status: Open
Sponsor: Coop/COG
Disease Program: Pediatrics

Next Steps


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Purpose

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.
Condition Title Intervention Phase
Alveolar Rhabdomyosarcoma Botryoid-Type Embryonal Rhabdomyosarcoma Embryonal Rhabdomyosarcoma Rhabdomyosarcoma Sclerosing Rhabdomyosarcoma Spindle Cell Rhabdomyosarcoma Untreated Childhood Rhabdomyosarcoma Cyclophosphamide Dactinomycin Irinotecan Hydrochloride Laboratory Biomarker Analysis Questionnaire Administration Radiation Therapy Temsirolimus Vincristine Sulfate Vinorelbine Phase 3
Study Type Interventional
Official Title A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Primary Outcome Measures

Event-free survival (EFS) [Time Frame: Time from study enrollment to the first occurrence of progression, relapse, second malignant neoplasm or death as a first event] [Designated as safety issue: ]


Secondary Outcome Measures

Overall survival (OS) [Time Frame: Time from study enrollment to death from any cause, assessed up to 10 years] [Designated as safety issue: ]

Estimated Enrollment: 397
Study Start Date: May 2016
Estimated Study Completion Date:
Estimated Primary Completion Date: January 2025
Arms Assigned Interventions

Experimental: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 PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Drug:Vincristine Sulfate
Given IV

Experimental: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.
Drug:Vinorelbine
Given IV

Experimental:Regimen C (FOXO1 fusion negative, VAC/VA)

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.

Eligibility

Ages Eligible for Study: 40 Years-40 Years

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02567435

Locations

  • United States, Alabama
    • Children's Hospital of Alabama Birmingham, Alabama, United States, 35233
    • USA Health Strada Patient Care Center Mobile, Alabama, United States, 36604
  • United States, Alaska
    • Anchorage Associates in Radiation Medicine Anchorage, Alaska, United States, 98508
    • Anchorage Radiation Therapy Center Anchorage, Alaska, United States, 99504
    • Alaska Breast Care and Surgery LLC Anchorage, Alaska, United States, 99508
    • Alaska Oncology and Hematology LLC Anchorage, Alaska, United States, 99508
    • Alaska Women's Cancer Care Anchorage, Alaska, United States, 99508
    • Anchorage Oncology Centre Anchorage, Alaska, United States, 99508
    • Katmai Oncology Group Anchorage, Alaska, United States, 99508
    • Providence Alaska Medical Center Anchorage, Alaska, United States, 99508
  • United States, Arizona
    • Cardon Children's Medical Center Mesa, Arizona, United States, 85202
    • Phoenix Childrens Hospital Phoenix, Arizona, United States, 85016
    • Mayo Clinic Hospital Phoenix, Arizona, United States, 85054
    • Mayo Clinic in Arizona Scottsdale, Arizona, United States, 85259
    • Banner University Medical Center - Tucson Tucson, Arizona, United States, 85719
  • United States, Arkansas
    • Arkansas Children's Hospital Little Rock, Arkansas, United States, 72202-3591
  • United States, California
    • Kaiser Permanente-Anaheim Anaheim, California, United States, 92806
    • PCR Oncology Arroyo Grande, California, United States, 93420
    • Kaiser Permanente-Bellflower Bellflower, California, United States, 90706
    • Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California, United States, 91505
    • Kaiser Permanente Downey Medical Center Downey, California, United States, 90242
    • Kaiser Permanente-Fontana Fontana, California, United States, 92335
    • Loma Linda University Medical Center Loma Linda, California, United States, 92354
    • Children's Hospital Los Angeles Los Angeles, California, United States, 90027
    • Kaiser Permanente Los Angeles Medical Center Los Angeles, California, United States, 90027
    • Mattel Children's Hospital UCLA Los Angeles, California, United States, 90095
    • UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California, United States, 90095
    • Valley Children's Hospital Madera, California, United States, 93636
    • Children's Hospital and Research Center at Oakland Oakland, California, United States, 94609-1809
    • Kaiser Permanente-Oakland Oakland, California, United States, 94611
    • Children's Hospital of Orange County Orange, California, United States, 92868
    • Lucile Packard Children's Hospital Stanford University Palo Alto, California, United States, 94304
    • Kaiser Permanente-Roseville Roseville, California, United States, 95661
    • University of California Davis Comprehensive Cancer Center Sacramento, California, United States, 95817
    • Kaiser Permanente-San Diego Mission San Diego, California, United States, 92108
    • Rady Children's Hospital - San Diego San Diego, California, United States, 92123
    • Naval Medical Center -San Diego San Diego, California, United States, 92134
    • UCSF Medical Center-Mission Bay San Francisco, California, United States, 94158
    • Kaiser Permanente Medical Center - Santa Clara Santa Clara, California, United States, 95051
    • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Torrance, California, United States, 90502
  • United States, Colorado
    • Children's Hospital Colorado Aurora, Colorado, United States, 80045
    • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado, United States, 80218
  • United States, Connecticut
    • Connecticut Children's Medical Center Hartford, Connecticut, United States, 06106
    • Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut, United States, 06510
    • Yale University New Haven, Connecticut, United States, 06520
    • Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut, United States, 06611
  • United States, Delaware
    • Alfred I duPont Hospital for Children Wilmington, Delaware, United States, 19803
  • United States, District of Columbia
    • Kaiser Permanente-Capitol Hill Medical Center Washington, District of Columbia, United States, 20002
    • Children's National Medical Center Washington, District of Columbia, United States, 20010
    • Sibley Memorial Hospital Washington, District of Columbia, United States, 20016
  • United States, Florida
    • Golisano Children's Hospital of Southwest Florida Fort Myers, Florida, United States, 33908
    • University of Florida Health Science Center - Gainesville Gainesville, Florida, United States, 32610
    • Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida, United States, 33021
    • Nemours Children's Clinic-Jacksonville Jacksonville, Florida, United States, 32207
    • Palms West Radiation Therapy Loxahatchee Groves, Florida, United States, 33470
    • University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida, United States, 33136
    • Nicklaus Children's Hospital Miami, Florida, United States, 33155
    • AdventHealth Orlando Orlando, Florida, United States, 32803
    • Arnold Palmer Hospital for Children Orlando, Florida, United States, 32806
    • Nemours Children's Hospital Orlando, Florida, United States, 32827
    • Nemours Children's Clinic - Pensacola Pensacola, Florida, United States, 32504
    • Johns Hopkins All Children's Hospital Saint Petersburg, Florida, United States, 33701
    • Tampa General Hospital Tampa, Florida, United States, 33606
    • Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida, United States, 33607
    • Saint Mary's Hospital West Palm Beach, Florida, United States, 33407
  • United States, Georgia
    • Children's Healthcare of Atlanta - Egleston Atlanta, Georgia, United States, 30322
    • Augusta University Medical Center Augusta, Georgia, United States, 30912
    • Medical Center of Central Georgia Macon, Georgia, United States, 31201
    • Memorial Health University Medical Center Savannah, Georgia, United States, 31404
  • United States, Hawaii
    • Straub Clinic and Hospital Honolulu, Hawaii, United States, 96813
    • Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii, United States, 96819
    • Kapiolani Medical Center for Women and Children Honolulu, Hawaii, United States, 96826
  • United States, Idaho
    • Saint Luke's Mountain States Tumor Institute Boise, Idaho, United States, 83712
    • Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland, Idaho, United States, 83619
    • Saint Luke's Mountain States Tumor Institute - Meridian Meridian, Idaho, United States, 83642
    • Saint Luke's Mountain States Tumor Institute - Nampa Nampa, Idaho, United States, 83686
    • Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls, Idaho, United States, 83301
  • United States, Illinois
    • Lurie Children's Hospital-Chicago Chicago, Illinois, United States, 60611
    • John H Stroger Jr Hospital of Cook County Chicago, Illinois, United States, 60612
    • Rush University Medical Center Chicago, Illinois, United States, 60612
    • University of Illinois Chicago, Illinois, United States, 60612
    • University of Chicago Comprehensive Cancer Center Chicago, Illinois, United States, 60637
    • Loyola University Medical Center Maywood, Illinois, United States, 60153
    • Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois, United States, 60453
    • Advocate Children's Hospital-Park Ridge Park Ridge, Illinois, United States, 60068
    • Saint Jude Midwest Affiliate Peoria, Illinois, United States, 61637
    • Saint John's Hospital Springfield, Illinois, United States, 62702
    • Southern Illinois University School of Medicine Springfield, Illinois, United States, 62702
    • Memorial Medical Center Springfield, Illinois, United States, 62781
  • United States, Indiana
    • Riley Hospital for Children Indianapolis, Indiana, United States, 46202
    • Saint Vincent Hospital and Health Care Center Indianapolis, Indiana, United States, 46260
  • United States, Iowa
    • Blank Children's Hospital Des Moines, Iowa, United States, 50309
    • Iowa Methodist Medical Center Des Moines, Iowa, United States, 50309
    • Iowa Lutheran Hospital Des Moines, Iowa, United States, 50316
    • University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa, United States, 52242
  • United States, Kentucky
    • University of Kentucky/Markey Cancer Center Lexington, Kentucky, United States, 40536
    • Norton Children's Hospital Louisville, Kentucky, United States, 40202
  • United States, Louisiana
    • Children's Hospital New Orleans New Orleans, Louisiana, United States, 70118
    • Ochsner Medical Center Jefferson New Orleans, Louisiana, United States, 70121
  • United States, Maine
    • Eastern Maine Medical Center Bangor, Maine, United States, 04401
    • Maine Children's Cancer Program Scarborough, Maine, United States, 04074
  • United States, Maryland
    • University of Maryland/Greenebaum Cancer Center Baltimore, Maryland, United States, 21201
    • Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland, United States, 21287
    • Walter Reed National Military Medical Center Bethesda, Maryland, United States, 20889-5600
  • United States, Massachusetts
    • Floating Hospital for Children at Tufts Medical Center Boston, Massachusetts, United States, 02111
    • Massachusetts General Hospital Cancer Center Boston, Massachusetts, United States, 02114
    • Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02215
    • University of Massachusetts Medical School Worcester, Massachusetts, United States, 01655
  • United States, Michigan
    • C S Mott Children's Hospital Ann Arbor, Michigan, United States, 48109
    • University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan, United States, 48109
    • Bronson Battle Creek Battle Creek, Michigan, United States, 49017
    • Wayne State University/Karmanos Cancer Institute Detroit, Michigan, United States, 48201
    • Ascension Saint John Hospital Detroit, Michigan, United States, 48236
    • Michigan State University Clinical Center East Lansing, Michigan, United States, 48824-7016
    • Hurley Medical Center Flint, Michigan, United States, 48503
    • Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan, United States, 49503
    • Mercy Health Saint Mary's Grand Rapids, Michigan, United States, 49503
    • Spectrum Health at Butterworth Campus Grand Rapids, Michigan, United States, 49503
    • Bronson Methodist Hospital Kalamazoo, Michigan, United States, 49007
    • West Michigan Cancer Center Kalamazoo, Michigan, United States, 49007
    • Borgess Medical Center Kalamazoo, Michigan, United States, 49048
    • Sparrow Hospital Lansing, Michigan, United States, 48912
    • Mercy Health Mercy Campus Muskegon, Michigan, United States, 49444
    • Lakeland Hospital Niles Niles, Michigan, United States, 49120
    • Huron Medical Center PC Port Huron, Michigan, United States, 48060
    • Lake Huron Medical Center Port Huron, Michigan, United States, 48060
    • Spectrum Health Reed City Hospital Reed City, Michigan, United States, 49677
    • Beaumont Children's Hospital-Royal Oak Royal Oak, Michigan, United States, 48073
    • Lakeland Medical Center Saint Joseph Saint Joseph, Michigan, United States, 49085
    • Marie Yeager Cancer Center Saint Joseph, Michigan, United States, 49085
    • Munson Medical Center Traverse City, Michigan, United States, 49684
    • Metro Health Hospital Wyoming, Michigan, United States, 49519
  • United States, Minnesota
    • Essentia Health Cancer Center Duluth, Minnesota, United States, 55805
    • Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota, United States, 55404
    • University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota, United States, 55455
    • Mayo Clinic Rochester, Minnesota, United States, 55905
  • United States, Mississippi
    • University of Mississippi Medical Center Jackson, Mississippi, United States, 39216
  • United States, Missouri
    • Columbia Regional Columbia, Missouri, United States, 65201
    • Siteman Cancer Center at West County Hospital Creve Coeur, Missouri, United States, 63141
    • Children's Mercy Hospitals and Clinics Kansas City, Missouri, United States, 64108
    • Cardinal Glennon Children's Medical Center Saint Louis, Missouri, United States, 63104
    • Barnes-Jewish Hospital Saint Louis, Missouri, United States, 63110
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
    • Mercy Hospital Saint Louis Saint Louis, Missouri, United States, 63141
    • Siteman Cancer Center at Saint Peters Hospital Saint Peters, Missouri, United States, 63376
  • United States, Montana
    • Saint Patrick Hospital - Community Hospital Missoula, Montana, United States, 59802
  • United States, Nebraska
    • Children's Hospital and Medical Center of Omaha Omaha, Nebraska, United States, 68114
    • University of Nebraska Medical Center Omaha, Nebraska, United States, 68198
  • United States, Nevada
    • Carson Tahoe Regional Medical Center Carson City, Nevada, United States, 89703
    • Cancer and Blood Specialists-Henderson Henderson, Nevada, United States, 89052
    • Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada, United States, 89052
    • Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada, United States, 89052
    • Las Vegas Cancer Center-Henderson Henderson, Nevada, United States, 89052
    • OptumCare Cancer Care at Seven Hills Henderson, Nevada, United States, 89052
    • 21st Century Oncology-Henderson Henderson, Nevada, United States, 89074
    • Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada, United States, 89074
    • Desert West Surgery Las Vegas, Nevada, United States, 89102
    • University Medical Center of Southern Nevada Las Vegas, Nevada, United States, 89102
    • Cancer and Blood Specialists-Shadow Las Vegas, Nevada, United States, 89106
    • OptumCare Cancer Care at Oakey Las Vegas, Nevada, United States, 89106
    • Radiation Oncology Centers of Nevada Central Las Vegas, Nevada, United States, 89106
    • 21st Century Oncology Las Vegas, Nevada, United States, 89109
    • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas, Nevada, United States, 89109
    • Sunrise Hospital and Medical Center Las Vegas, Nevada, United States, 89109
    • HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas, Nevada, United States, 89113
    • Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada, United States, 89119
    • Cancer Therapy and Integrative Medicine Las Vegas, Nevada, United States, 89121
    • 21st Century Oncology-Vegas Tenaya Las Vegas, Nevada, United States, 89128
    • Ann M Wierman MD LTD Las Vegas, Nevada, United States, 89128
    • Cancer and Blood Specialists-Tenaya Las Vegas, Nevada, United States, 89128
    • Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada, United States, 89128
    • HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas, Nevada, United States, 89128
    • OptumCare Cancer Care at MountainView Las Vegas, Nevada, United States, 89128
    • Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada, United States, 89135
    • Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada, United States, 89144
    • Summerlin Hospital Medical Center Las Vegas, Nevada, United States, 89144
    • Las Vegas Cancer Center-Medical Center Las Vegas, Nevada, United States, 89148-2405
    • 21st Century Oncology-Fort Apache Las Vegas, Nevada, United States, 89148
    • Comprehensive Cancer Centers of Nevada Las Vegas, Nevada, United States, 89148
    • OptumCare Cancer Care at Fort Apache Las Vegas, Nevada, United States, 89148
    • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas, Nevada, United States, 89149
    • Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada, United States, 89169
    • University Cancer Center Las Vegas, Nevada, United States, 89169
    • Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada, United States, 89048
    • Renown Regional Medical Center Reno, Nevada, United States, 89502
    • Saint Mary's Regional Medical Center Reno, Nevada, United States, 89503
    • Radiation Oncology Associates Reno, Nevada, United States, 89509
  • United States, New Hampshire
    • Dartmouth Hitchcock Medical Center Lebanon, New Hampshire, United States, 03756
  • United States, New Jersey
    • Hackensack University Medical Center Hackensack, New Jersey, United States, 07601
    • Morristown Medical Center Morristown, New Jersey, United States, 07960
    • Saint Peter's University Hospital New Brunswick, New Jersey, United States, 08901
    • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey, United States, 08903
    • Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey, United States, 08903
    • Newark Beth Israel Medical Center Newark, New Jersey, United States, 07112
    • Saint Joseph's Regional Medical Center Paterson, New Jersey, United States, 07503
  • United States, New York
    • Albany Medical Center Albany, New York, United States, 12208
    • Montefiore Medical Center-Einstein Campus Bronx, New York, United States, 10461
    • Montefiore Medical Center-Weiler Hospital Bronx, New York, United States, 10461
    • Children's Hospital at Montefiore Bronx, New York, United States, 10467
    • Montefiore Medical Center - Moses Campus Bronx, New York, United States, 10467
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14263
    • Glens Falls Hospital Glens Falls, New York, United States, 12801
    • NYU Winthrop Hospital Mineola, New York, United States, 11501
    • The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York, United States, 11040
    • Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York, United States, 10016
    • Mount Sinai Hospital New York, New York, United States, 10029
    • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York, United States, 10032
    • University of Rochester Rochester, New York, United States, 14642
    • Stony Brook University Medical Center Stony Brook, New York, United States, 11794
    • State University of New York Upstate Medical University Syracuse, New York, United States, 13210
    • New York Medical College Valhalla, New York, United States, 10595
    • Westchester Medical Center Valhalla, New York, United States, 10595
  • United States, North Carolina
    • Mission Hospital Inc-Memorial Campus Asheville, North Carolina, United States, 28801
    • UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina, United States, 27599
    • Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina, United States, 28203
    • Novant Health Presbyterian Medical Center Charlotte, North Carolina, United States, 28204
    • Carolina Surgical Clinic of Charlotte PA Charlotte, North Carolina, United States, 28207
    • Oncology Specialists of Charlotte Charlotte, North Carolina, United States, 28207
    • Southern Oncology Specialists-Charlotte Charlotte, North Carolina, United States, 28262
    • Duke University Medical Center Durham, North Carolina, United States, 27710
    • East Carolina University Greenville, North Carolina, United States, 27834
    • Lake Norman Hematology Oncology Specialists-Huntersville Huntersville, North Carolina, United States, 28078
    • Novant Health Presbyterian Medical Center Huntersville Huntersville, North Carolina, United States, 28078
    • Southern Oncology Specialists-Huntersville Huntersville, North Carolina, United States, 28078
    • Matthews Radiation Oncology Center Matthews, North Carolina, United States, 28105
    • Novant Health Cancer Specialists-Matthews Matthews, North Carolina, United States, 28105
    • Lake Norman Hematology Oncology Specialists-Mooresville Mooresville, North Carolina, United States, 28117
    • Lake Norman Radiation Oncology Center-Mooresville Mooresville, North Carolina, United States, 28117
    • Carolina Oncology Associates PA Salisbury, North Carolina, United States, 28144
    • Rowan Regional Medical Center Salisbury, North Carolina, United States, 28144
    • Wake Forest University Health Sciences Winston-Salem, North Carolina, United States, 27157
  • United States, North Dakota
    • Sanford Broadway Medical Center Fargo, North Dakota, United States, 58122
  • United States, Ohio
    • Children's Hospital Medical Center of Akron Akron, Ohio, United States, 44308
    • Cincinnati Children's Hospital Medical Center Cincinnati, Ohio, United States, 45229
    • Rainbow Babies and Childrens Hospital Cleveland, Ohio, United States, 44106
    • Cleveland Clinic Foundation Cleveland, Ohio, United States, 44195
    • Nationwide Children's Hospital Columbus, Ohio, United States, 43205
    • Dayton Children's Hospital Dayton, Ohio, United States, 45404
    • ProMedica Flower Hospital Sylvania, Ohio, United States, 43560
    • The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio, United States, 43606
  • United States, Oklahoma
    • University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma, United States, 73104
  • United States, Oregon
    • Saint Charles Health System Bend, Oregon, United States, 97701
    • Clackamas Radiation Oncology Center Clackamas, Oregon, United States, 97015
    • Providence Oncology and Hematology Care Southeast Clackamas, Oregon, United States, 97015
    • Bay Area Hospital Coos Bay, Oregon, United States, 97420
    • Providence Newberg Medical Center Newberg, Oregon, United States, 97132
    • Providence Portland Medical Center Portland, Oregon, United States, 97213
    • Providence Saint Vincent Medical Center Portland, Oregon, United States, 97225
    • Legacy Emanuel Children's Hospital Portland, Oregon, United States, 97227
    • Oregon Health and Science University Portland, Oregon, United States, 97239
  • United States, Pennsylvania
    • Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania, United States, 18103
    • Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania, United States, 18017
    • Geisinger Medical Center Danville, Pennsylvania, United States, 17822
    • Penn State Children's Hospital Hershey, Pennsylvania, United States, 17033
    • Children's Hospital of Philadelphia Philadelphia, Pennsylvania, United States, 19104
    • Saint Christopher's Hospital for Children Philadelphia, Pennsylvania, United States, 19134
    • Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania, United States, 15224
  • United States, Rhode Island
    • Rhode Island Hospital Providence, Rhode Island, United States, 02903
  • United States, South Carolina
    • Medical University of South Carolina Charleston, South Carolina, United States, 29425
    • Prisma Health Richland Hospital Columbia, South Carolina, United States, 29203
    • BI-LO Charities Children's Cancer Center Greenville, South Carolina, United States, 29605
  • United States, South Dakota
    • Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota, United States, 57117-5134
  • United States, Tennessee
    • T C Thompson Children's Hospital Chattanooga, Tennessee, United States, 37403
    • East Tennessee Childrens Hospital Knoxville, Tennessee, United States, 37916
    • The Children's Hospital at TriStar Centennial Nashville, Tennessee, United States, 37203
    • Vanderbilt University/Ingram Cancer Center Nashville, Tennessee, United States, 37232
  • United States, Texas
    • Dell Children's Medical Center of Central Texas Austin, Texas, United States, 78723
    • Driscoll Children's Hospital Corpus Christi, Texas, United States, 78411
    • Medical City Dallas Hospital Dallas, Texas, United States, 75230
    • UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas, United States, 75390
    • El Paso Children's Hospital El Paso, Texas, United States, 79905
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas, United States, 77030
    • M D Anderson Cancer Center Houston, Texas, United States, 77030
    • Covenant Children's Hospital Lubbock, Texas, United States, 79410
    • University Medical Center Lubbock, Texas, United States, 79415
    • Texas Tech University Health Sciences Center-Lubbock Lubbock, Texas, United States, 79430
    • Children's Hospital of San Antonio San Antonio, Texas, United States, 78207
    • Cancer Therapy and Research Center at The UT Health Science Center at San Antonio San Antonio, Texas, United States, 78229
    • Methodist Children's Hospital of South Texas San Antonio, Texas, United States, 78229
    • University Hospital San Antonio, Texas, United States, 78229
    • University of Texas Health Science Center at San Antonio San Antonio, Texas, United States, 78229
    • Scott and White Memorial Hospital Temple, Texas, United States, 76508
  • United States, Utah
    • Primary Children's Hospital Salt Lake City, Utah, United States, 84113
  • United States, Vermont
    • Central Vermont Medical Center/National Life Cancer Treatment Berlin, Vermont, United States, 05602
    • University of Vermont Medical Center Burlington, Vermont, United States, 05401
    • University of Vermont and State Agricultural College Burlington, Vermont, United States, 05405
  • United States, Virginia
    • University of Virginia Cancer Center Charlottesville, Virginia, United States, 22908
    • Inova Fairfax Hospital Falls Church, Virginia, United States, 22042
    • Children's Hospital of The King's Daughters Norfolk, Virginia, United States, 23507
    • Naval Medical Center - Portsmouth Portsmouth, Virginia, United States, 23708-2197
  • United States, Washington
    • Providence Regional Cancer System-Aberdeen Aberdeen, Washington, United States, 98520
    • PeaceHealth Saint Joseph Medical Center Bellingham, Washington, United States, 98225
    • Providence Regional Cancer System-Centralia Centralia, Washington, United States, 98531
    • Swedish Cancer Institute-Edmonds Edmonds, Washington, United States, 98026
    • Providence Regional Cancer Partnership Everett, Washington, United States, 98201
    • Swedish Cancer Institute-Issaquah Issaquah, Washington, United States, 98029
    • Kadlec Clinic Hematology and Oncology Kennewick, Washington, United States, 99336
    • Providence Regional Cancer System-Lacey Lacey, Washington, United States, 98503
    • PeaceHealth Saint John Medical Center Longview, Washington, United States, 98632
    • Pacific Gynecology Specialists Seattle, Washington, United States, 98104
    • Seattle Children's Hospital Seattle, Washington, United States, 98105
    • Swedish Medical Center-Ballard Campus Seattle, Washington, United States, 98107
    • Kaiser Permanente Washington Seattle, Washington, United States, 98112
    • Swedish Medical Center-First Hill Seattle, Washington, United States, 98122-4307
    • Swedish Medical Center-Cherry Hill Seattle, Washington, United States, 98122-5711
    • University of Washington Medical Center Seattle, Washington, United States, 98195
    • Providence Regional Cancer System-Shelton Shelton, Washington, United States, 98584
    • Rockwood Clinic Cancer Treatment Center-Valley Spokane Valley, Washington, United States, 99216
    • Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington, United States, 99204
    • Rockwood Cancer Treatment Center-DHEC-Downtown Spokane, Washington, United States, 99204
    • Rockwood North Cancer Treatment Center Spokane, Washington, United States, 99218
    • Mary Bridge Children's Hospital and Health Center Tacoma, Washington, United States, 98405
    • Madigan Army Medical Center Tacoma, Washington, United States, 98431
    • PeaceHealth Southwest Medical Center Vancouver, Washington, United States, 98664
    • Providence Saint Mary Regional Cancer Center Walla Walla, Washington, United States, 99362
    • Providence Regional Cancer System-Yelm Yelm, Washington, United States, 98597
  • United States, West Virginia
    • United Hospital Center Bridgeport, West Virginia, United States, 26330
    • WVUH-Berkely Medical Center Martinsburg, West Virginia, United States, 25401
    • West Virginia University Healthcare Morgantown, West Virginia, United States, 26506
    • Camden Clark Medical Center Parkersburg, West Virginia, United States, 26101
  • United States, Wisconsin
    • Gundersen Lutheran Medical Center La Crosse, Wisconsin, United States, 54601
    • University of Wisconsin Hospital and Clinics Madison, Wisconsin, United States, 53792
    • Marshfield Medical Center-Marshfield Marshfield, Wisconsin, United States, 54449
    • Children's Hospital of Wisconsin Milwaukee, Wisconsin, United States, 53226
  • Australia, New South Wales
    • John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales, Australia, 2310
    • Sydney Children's Hospital Randwick, New South Wales, Australia, 2031
    • The Children's Hospital at Westmead Westmead, New South Wales, Australia, 2145
  • Australia, Queensland
    • Queensland Children's Hospital South Brisbane, Queensland, Australia, 4101
  • Australia, Western Australia
    • Princess Margaret Hospital for Children Perth, Western Australia, Australia, 6008
    • Perth Children's Hospital Perth, Western Australia, Australia, 6009
  • Canada, British Columbia
    • British Columbia Children's Hospital Vancouver, British Columbia, Canada, V6H 3V4
  • Canada, Manitoba
    • CancerCare Manitoba Winnipeg, Manitoba, Canada, R3E 0V9
  • Canada, Newfoundland and Labrador
    • Janeway Child Health Centre Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
  • Canada, Nova Scotia
    • IWK Health Centre Halifax, Nova Scotia, Canada, B3K 6R8
  • Canada, Ontario
    • McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario, Canada, L8N 3Z5
    • Kingston Health Sciences Centre Kingston, Ontario, Canada, K7L 2V7
    • Children's Hospital London, Ontario, Canada, N6A 5W9
    • Children's Hospital of Eastern Ontario Ottawa, Ontario, Canada, K1H 8L1
    • Hospital for Sick Children Toronto, Ontario, Canada, M5G 1X8
  • Canada, Quebec
    • The Montreal Children's Hospital of the MUHC Montreal, Quebec, Canada, H3H 1P3
    • Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec, Canada, H3T 1C5
  • Canada, Saskatchewan
    • Saskatoon Cancer Centre Saskatoon, Saskatchewan, Canada, S7N 4H4
  • Canada,
    • Centre Hospitalier Universitaire de Quebec Quebec, , Canada, G1V 4G2
  • New Zealand, Auckland
    • Starship Children's Hospital Grafton, Auckland, New Zealand, 1145
  • New Zealand,
    • Christchurch Hospital Christchurch, , New Zealand, 8011
  • Puerto Rico,
    • HIMA San Pablo Oncologic Hospital Caguas, , Puerto Rico, 00726
    • San Jorge Children's Hospital San Juan, , Puerto Rico, 00912
    • University Pediatric Hospital San Juan, , Puerto Rico, 00926

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02567435
Other Study ID Numbers: NCI-2015-01644
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Rhabdomyosarcoma

Rhabdomyosarcoma, Embryonal

Rhabdomyosarcoma, Alveolar

Cyclophosphamide

Everolimus

Sirolimus

Irinotecan

Vincristine

Vinorelbine

Camptothecin

Dactinomycin

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019