Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor (PNET) of the bone or soft tissues Diagnostic biopsy of primary tumor within 30 days of study Paraspinal or bony skull tumors of extradural origin allowed No intradural soft tissue tumors Askin's tumor of the chest wall allowed Chest wall tumors with ipsilateral pleural effusions or ipsilateral pleural-based secondary tumor nodules allowed No contralateral pleural effusions No metastatic disease or distant node involvement One pulmonary or pleural nodule greater than 1 cm in diameter OR more than 1 nodule greater than 0.5 cm in diameter are considered pulmonary metastasis Solitary lung nodules of 0.5-1 cm OR multiple nodules of 0.3-0.5 cm allowed unless biopsy positive for tumor Light microscopic appearance (hematoxylin and eosin stained) consistent with Ewing's sarcoma or peripheral PNET No immunohistochemical or ultrastructural evidence of rhabdomyosarcoma No esthesioneuroblastoma Clinically or pathologically involved regional lymph nodes allowed No CNS involvement PATIENT CHARACTERISTICS: Age: 50 and under at diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine normal for age Creatinine clearance or isotope glomerular filtration rate at least 75 mL/min Cardiovascular: Shortening fraction at least 28% by echocardiography OR Ejection fraction at least 55% by radionuclide angiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy except skin cancer diagnosed at least 5 years ago and currently in remission PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for skin cancer No concurrent sargramostim (GM-CSF) No concurrent pegfilgrastim Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Prior complete or partial excision of primary tumor allowed
Sites / Locations
- Comprehensive Cancer Center at University of Alabama at Birmingham
- University of South Alabama Cancer Research Institute
- Phoenix Children's Hospital
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- City of Hope Comprehensive Cancer Center
- Rebecca and John Moores UCSD Cancer Center
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
- Children's Hospital Los Angeles
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
- Jonsson Comprehensive Cancer Center at UCLA
- Children's Hospital Central California
- Children's Hospital and Research Center at Oakland
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- Children's Hospital of Orange County
- Lucile Packard Children's Hospital at Stanford University Medical Center
- Sutter Cancer Center
- University of California Davis Cancer Center
- Kaiser Permanente Medical Center - Sacramento
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
- Children's Hospital and Health Center - San Diego
- UCSF Comprehensive Cancer Center
- Santa Barbara Cottage Hospital
- Kaiser Permanente Medical Center - Santa Clara
- General Robert Huyser Cancer Center at David Grant Medical Center
- Children's Hospital Cancer Center
- Presbyterian - St. Luke's Medical Center
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Yale Comprehensive Cancer Center
- Alfred I. duPont Hospital for Children
- Lombardi Cancer Center at Georgetown University Medical Center
- Children's National Medical Center
- Broward General Medical Center
- Children's Hospital of Southwest Florida
- University of Florida Shands Cancer Center
- Joe DiMaggio Children's Hospital at Memorial
- Nemours Children's Clinic
- Jackson Memorial Hospital
- Miami Children's Hospital
- Baptist-South Miami Regional Cancer Program
- Florida Hospital Cancer Institute
- Nemours Children's Clinic-Orlando
- Sacred Heart Children's Hospital
- All Children's Hospital
- St. Joseph's Children's Hospital of Tampa
- Kaplan Cancer Center at St. Mary's Medical Center
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
- MBCCOP-Medical College of Georgia Cancer Center
- Medical Center of Central Georgia
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Cancer Research Center of Hawaii
- Tripler Army Medical Center
- St. Luke's Mountain States Tumor Institute - Boise
- University of Chicago Cancer Research Center
- Rush University Medical Center
- University of Illinois Medical Center
- Children's Memorial Hospital - Chicago
- Advocate Hope Children's Hospital
- Lutheran General Cancer Care Center
- Saint Jude Midwest Affiliate
- Southern Illinois University School of Medicine
- Riley Children Cancer Center at Riley Hospital for Children
- St. Vincent Hospitals and Health Care Centers
- Blank Children's Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- Wesley Medical Center
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Kosair Children's Hospital
- MBCCOP - LSU Health Sciences Center
- Tulane Cancer Center at Tulane University Hospital and Clinic
- Children's Hospital of New Orleans
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- Pediatric Specialty Clinic at Eastern Maine Medical Center
- Maine Children's Cancer Program
- Greenebaum Cancer Center at University of Maryland Medical Center
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Walter Reed Army Medical Center
- Floating Hospital for Children
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
- UMASS Memorial Cancer Center - University Campus
- University of Michigan Comprehensive Cancer Center
- Children's Hospital of Michigan
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Hurley Medical Center
- DeVos Children's Hospital
- Bronson Methodist Hospital
- Breslin Cancer Center at Ingham Regional Medical Center
- William Beaumont Hospital - Royal Oak Campus
- St. Mary's - Duluth Clinic Cancer Center
- Children's Hospitals and Clinics - Minneapolis/St. Paul
- Mayo Clinic Cancer Center
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Cardinal Glennon Children's Hospital
- St. Louis Children's Hospital
- CCOP - Montana Cancer Consortium
- Great Falls Clinic
- Sletten Regional Cancer Institute
- Children's Hospital of Omaha
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Sunrise Hospital and Medical Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Cancer Center at Hackensack University Medical Center
- St. Barnabas Medical Center
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Newark Beth Israel Medical Center
- St. Joseph's Hospital and Medical Center
- Valerie Fund Children's Center at Atlantic Health
- University of New Mexico Cancer Research and Treatment Center
- Children's Hospital at Albany Medical Center
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Brooklyn Hospital Center
- SUNY Downstate Medical Center
- Brookdale University Hospital and Medical Center
- Comprehensive Cancer Center at Maimonides Medical Center
- Roswell Park Cancer Institute
- Schneider Children's Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Long Island Cancer Center at Stony Brook University Hospital
- SUNY Upstate Medical University Hospital
- New York Medical College
- Mission Hospitals - Memorial Campus
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Duke Comprehensive Cancer Center
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Cleveland Clinic Taussig Cancer Center
- Columbus Children's Hospital
- Children's Medical Center - Dayton
- Toledo Children's Hospital
- Tod Children's Hospital - Forum Health
- Children's Hospital at Oklahoma University Medical Center
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- CCOP - Columbia River Oncology Program
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Doernbecher Children's Hospital at Oregon Health & Science University
- Geisinger Medical Center
- Penn State Children's Hospital
- Children's Hospital of Philadelphia
- St. Christopher's Hospital for Children
- Children's Hospital of Pittsburgh
- Hollings Cancer Center at Medical University of South Carolina
- Palmetto Health South Carolina Cancer Center
- Children's Hospital of Greenville Hospital System
- Avera Cancer Institute
- Sioux Valley Hospital and University of South Dakota Medical Center
- East Tennessee State University Cancer Center at Johnson City Medical Center
- East Tennessee Children's Hospital
- St. Jude Children's Research Hospital
- Vanderbilt Children's Hospital
- Texas Tech University Health Sciences Center School of Medicine
- Medical City Dallas Hospital
- Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
- Brooke Army Medical Center
- Cook Children's Medical Center - Fort Worth
- University of Texas Medical Branch
- M.D. Anderson Cancer Center at University of Texas
- Baylor College of Medicine
- San Antonio Military Pediatric Cancer and Blood Disorders Center
- Wilford Hall Medical Center
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- MBCCOP - South Texas Pediatrics
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
- CCOP - Scott and White Hospital
- Center for Cancer Prevention and Care at Scott and White Clinic
- Huntsman Cancer Institute at University of Utah
- Vermont Cancer Center at University of Vermont
- Cancer Center at the University of Virginia
- INOVA Fairfax Hospital
- Children's Hospital of the King's Daughters
- Naval Medical Center - Portsmouth
- Massey Cancer Center at Virginia Commonwealth University
- Carilion Medical Center for Children at Roanoke Community Hospital
- St. Joseph Hospital Community Cancer Center
- Olympic Hematology and Oncology
- Cancer Care Center at Skagit Valley Hospital
- Harborview Medical Center
- Children's Hospital and Regional Medical Center - Seattle
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Deaconess Medical Center
- Madigan Army Medical Center
- Central Washington Hospital
- Wenatchee Valley Clinic
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
- Cabell Huntington Hospital
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- Bellin Memorial Hospital
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- St. Vincent Hospital
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Medical College of Ohio Cancer Institute
- University of Wisconsin Comprehensive Cancer Center
- Marshfield Clinic - Marshfield Center
- CCOP - Marshfield Clinic Research Foundation
- Midwest Children's Cancer Center
- Sydney Children's Hospital
- Children's Hospital at Westmead
- Royal Children's Hospital
- Women's and Children's Hospital
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- Cross Cancer Institute at University of Alberta
- British Columbia Children's Hospital
- CancerCare Manitoba
- Janeway Children's Health and Rehabilitation Centre
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Children's Hospital of Western Ontario
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Allan Blair Cancer Centre at Pasqua Hospital
- Saskatoon Cancer Centre
- University Medical Center Groningen
- Starship Children's Health
- Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
- San Jorge Children's Hospital
- Swiss Pediatric Oncology Group Bern
- Swiss Pediatric Oncology Group Geneva
- Swiss Pediatric Oncology Group Lausanne
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Regimen A
Regimen B
Test the hypothesis that chemotherapy given every two weeks (Regimen B) will produce higher event-free survival. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks (four cycles on Regimen A. The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide, etoposide, MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (Surgery, Radiation Therapy, or a combination) will begin on Week 13 which will be after four cycles of chemotherapy.
Conventional every-three-week chemotherapy for patients with Ewing sarcoma and related tumors. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks six cycles on Regimen B). The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide etoposide MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (surgery, Radiation Therapy, or a combination) will begin on Week 13, which will be after six cycles of chemotherapy.