Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
Adult Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma
About this trial
This is an interventional treatment trial for Adult Rhabdomyosarcoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting criteria for 1 of the following subsets: Subset 1, defined by meeting 1 of the following criteria (closed to accrual as of 08/13/2010): Stage 1 and clinical group I (completely resected) or II (microscopic residual disease and/or regional lymph node involvement) disease Stage 1 and clinical group III (gross residual disease) disease arising in the orbit Stage 2 and clinical group I or II disease Subset 2, defined by meeting 1 of the following criteria (closed to accrual as of 09/23/2011): Stage 1 and clinical group III disease arising in a non-orbit site Stage 3 and clinical group I or II disease Prior staging ipsilateral retroperitoneal lymph node dissection required for all patients age 10 and over with paratesticular tumors and patients under 10 years of age with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement is identified by imaging studies) If there is extensive gross node involvement only confirmatory node biopsy is recommended and the patient is classified as Clinical Group III Prior regional lymph node sampling required for patients with extremity tumors None of the following diagnoses: Intermediate-risk embryonal RMS Metastatic embryonal RMS Alveolar RMS Undifferentiated sarcoma RMS not otherwise specified (NOS) Other soft tissue sarcoma, including sarcoma NOS Prior enrollment on clinical trial COG-D9902 Performance status - ECOG 0-2 Performance status - Karnofsky 50-100% (≥ 16 years old) Performance status - Lansky 50-100% (< 16 years old) Absolute neutrophil count at least 750/mm^3 Platelet count at least 75,000/mm^3 (transfusion independent) Bilirubin no greater than 1.5 times upper limit of normal (ULN)* Creatinine* based on age/gender as follows: No greater than 0.8 mg/dL for patients age 5 and under No greater than 1.0 mg/dL for patients age 6 to 9 No greater than 1.2 mg/dL for patients age 10 to 12 No greater than 1.4 mg/dL for female patients age 13 and over No greater than 1.5 mg/dL for male patients age 13 to 15 No greater than 1.7 mg/dL for male patients age 16 and over Creatinine clearance* or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m^2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled infection No prior chemotherapy (except for patients treated on the related intermediate-risk study) Prior steroids allowed No prior radiotherapy
Sites / Locations
- University of Alabama at Birmingham
- Phoenix Childrens Hospital
- University of Arizona Health Sciences Center
- University of Arkansas for Medical Sciences
- Children's Oncology Group
- Southern California Permanente Medical Group
- Loma Linda University Medical Center
- Miller Children's Hospital
- Children's Hospital Los Angeles
- Cedars-Sinai Medical Center
- Children's Hospital Central California
- Children's Hospital and Research Center at Oakland
- Kaiser Permanente-Oakland
- Childrens Hospital of Orange County
- Lucile Packard Children's Hospital Stanford University
- UC Davis Comprehensive Cancer Center
- Rady Children's Hospital - San Diego
- University of California San Francisco Medical Center-Parnassus
- Children's Hospital Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
- Connecticut Children's Medical Center
- Children's National Medical Center
- Broward Health Medical Center
- Memorial Healthcare System - Joe DiMaggio Children's Hospital
- Nemours Children's Clinic - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Miami Children's Hospital
- Baptist Hospital of Miami
- M D Anderson Cancer Center- Orlando
- Nemours Children's Clinic - Pensacola
- All Children's Hospital
- Saint Joseph Children's Hospital of Tampa
- Saint Mary's Hospital
- Children's Healthcare of Atlanta - Egleston
- Memorial Health University Medical Center
- University of Hawaii
- Tripler Army Medical Center
- Saint Luke's Mountain States Tumor Institute
- University of Illinois
- Childrens Memorial Hospital
- University of Chicago Comprehensive Cancer Center
- Advocate Hope Children's Hospital
- Advocate Lutheran General Hospital
- Saint Jude Midwest Affiliate
- Southern Illinois University
- Indiana University Medical Center
- Raymond Blank Children's Hospital
- University of Iowa Hospitals and Clinics
- University of Kentucky
- Kosair Children's Hospital
- Tulane University Health Sciences Center
- Children's Hospital-Main Campus
- Eastern Maine Medical Center
- Maine Children's Cancer Program
- University of Maryland Greenebaum Cancer Center
- Sinai Hospital of Baltimore
- Johns Hopkins University
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
- Baystate Medical Center
- C S Mott Children's Hospital
- Wayne State University
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Michigan State University - Breslin Cancer Center
- William Beaumont Hospital
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- University of Minnesota Medical Center-Fairview
- Mayo Clinic
- University of Mississippi Medical Center
- The Childrens Mercy Hospital
- Cardinal Glennon Children's Medical Center
- Washington University School of Medicine
- Children's Hospital and Medical Center of Omaha
- University of Nebraska Medical Center
- Nevada Cancer Research Foundation CCOP
- Dartmouth Hitchcock Medical Center
- Hackensack University Medical Center
- UMDNJ - Robert Wood Johnson University Hospital
- Newark Beth Israel Medical Center
- University of New Mexico Cancer Center
- Albany Medical Center
- Montefiore Medical Center
- Brooklyn Hospital Center
- Roswell Park Cancer Institute
- The Steven and Alexandra Cohen Children's Medical Center of New York
- Mount Sinai Medical Center
- Columbia University Medical Center
- Memorial Sloan Kettering Cancer Center
- University of Rochester
- State University of New York Upstate Medical University
- New York Medical College
- Mission Hospitals Inc
- University of North Carolina
- Presbyterian Hospital
- Wake Forest University Health Sciences
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Childrens Hospital
- Cleveland Clinic Foundation
- Nationwide Children's Hospital
- The Children's Medical Center of Dayton
- Legacy Emanuel Hospital and Health Center
- Oregon Health and Science University
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Medical Center
- Penn State Hershey Children's Hospital
- Children's Hospital of Philadelphia
- Saint Christopher's Hospital for Children
- Children's Hospital of Pittsburgh of UPMC
- Medical University of South Carolina
- Greenville Cancer Treatment Center
- T C Thompson Children's Hospital
- East Tennessee Childrens Hospital
- St. Jude Children's Research Hospital
- Vanderbilt-Ingram Cancer Center
- Driscoll Children's Hospital
- Medical City Dallas Hospital
- University of Texas Southwestern Medical Center
- Cook Children's Medical Center
- Baylor College of Medicine
- M D Anderson Cancer Center
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Children's Hospital of South Texas
- Scott and White Memorial Hospital
- Primary Children's Medical Center
- University of Vermont
- University of Virginia
- Inova Fairfax Hospital
- Childrens Hospital-King's Daughters
- Virginia Commonwealth University
- Seattle Children's Hospital
- Providence Sacred Heart Medical Center and Children's Hospital
- West Virginia University Charleston
- Saint Vincent Hospital
- University of Wisconsin Hospital and Clinics
- Midwest Children's Cancer Center
- Sydney Children's Hospital
- The Children's Hospital at Westmead
- Sydney West Area Health Service-Westmead Hospital
- Royal Brisbane and Women's Hospital
- Women's and Children's Hospital-Adelaide
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- University of Alberta Hospital
- British Columbia Children's Hospital
- CancerCare Manitoba
- Janeway Child Health Centre
- Chedoke-McMaster Hospitals
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- The Montreal Children's Hospital of the MUHC
- Hospital Sainte-Justine
- Centre Hospitalier Universitaire de Quebec
- Allan Blair Cancer Centre
- Starship Children's Hospital
- Christchurch Hospital
- San Jorge Children's Hospital
- Swiss Pediatric Oncology Group - Geneva
- Swiss Pediatric Oncology Group - Lausanne
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Regimen I (chemotherapy, radiotherapy)
Regimen II (chemotherapy, radiotherapy, surgery)
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).