Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed tumor of the Ewing's family of bone or soft tissue Ewing's sarcoma Peripheral primitive neuroectodermal tumor Disease meeting one of the following criteria: Resectable localized disease (tumor volume less than 200 mL) Localized disease previously resected at diagnosis Unresectable disease (at least 200 mL tumor volume) but radiotherapy as local control can be delayed Localized disease with early radiotherapy required Pulmonary and/or pleural metastases only Extrapulmonary/pleural metastases (skeleton, bone marrow, lymph nodes) No more than 45 days since definitive biopsy PATIENT CHARACTERISTICS: Age: Under 50 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Renal function normal Glomerular filtration rate at least 60 mL/min Cardiovascular: Normal cardiac function Fractional shortening at least 29% Ejection fraction at least 40% Other: No medical, psychiatric, or social condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Sites / Locations
- UAB Comprehensive Cancer CenterRecruiting
- Phoenix Children's HospitalRecruiting
- Arkansas Cancer Research Center at University of Arkansas for Medical SciencesRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- Childrens Hospital Los AngelesRecruiting
- Southern California Permanente Medical GroupRecruiting
- Lucile Packard Children's Hospital at Stanford University Medical CenterRecruiting
- Kaiser Permanente Medical Center - OaklandRecruiting
- Rady Children's Hospital - San DiegoRecruiting
- UCSF Helen Diller Family Comprehensive Cancer CenterRecruiting
- Children's Hospital Colorado Center for Cancer and Blood DisordersRecruiting
- Alfred I. duPont Hospital for ChildrenRecruiting
- Children's National Medical CenterRecruiting
- Nemours Children's ClinicRecruiting
- University of Miami Sylvester Comprehensive Cancer Center - MiamiRecruiting
- Nemours Children's Clinic - OrlandoRecruiting
- Nemours Children's Clinic - PensacolaRecruiting
- All Children's HospitalRecruiting
- St. Joseph's Cancer Institute at St. Joseph's HospitalRecruiting
- Kaplan Cancer Center at St. Mary's Medical CenterRecruiting
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusRecruiting
- Cancer Research Center of HawaiiRecruiting
- Mountain States Tumor Institute at St. Luke's Regional Medical CenterRecruiting
- University of Chicago Cancer Research CenterRecruiting
- Saint Jude Midwest AffiliateRecruiting
- Simmons Cooper Cancer InstituteRecruiting
- Holden Comprehensive Cancer Center at University of IowaRecruiting
- Kosair Children's HospitalRecruiting
- Children's Hospital of New OrleansRecruiting
- Alvin and Lois Lapidus Cancer Institute at Sinai HospitalRecruiting
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Van Elslander Cancer Center at St. John Hospital and Medical CenterRecruiting
- Bronson Methodist HospitalRecruiting
- Breslin Cancer Center at Ingham Regional Medical CenterRecruiting
- CCOP - DuluthRecruiting
- Children's Hospitals and Clinics of Minnesota - MinneapolisRecruiting
- Masonic Cancer Center at University of MinnesotaRecruiting
- Mayo Clinic Cancer CenterRecruiting
- Children's Hospitals and Clinics of Minnesota - St. PaulRecruiting
- University of Mississippi Cancer ClinicRecruiting
- Children's Mercy HospitalRecruiting
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisRecruiting
- CCOP - Nevada Cancer Research FoundationRecruiting
- Hackensack University Medical Center Cancer CenterRecruiting
- Albert Einstein Cancer Center at Albert Einstein College of MedicineRecruiting
- Roswell Park Cancer InstituteRecruiting
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterRecruiting
- James P. Wilmot Cancer Center at University of Rochester Medical CenterRecruiting
- SUNY Upstate Medical University HospitalRecruiting
- Blumenthal Cancer Center at Carolinas Medical CenterRecruiting
- Presbyterian Cancer Center at Presbyterian HospitalRecruiting
- Duke Cancer InstituteRecruiting
- Leo W. Jenkins Cancer Center at ECU Medical SchoolRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- Rainbow Babies and Children's HospitalRecruiting
- Cleveland Clinic Taussig Cancer CenterRecruiting
- Nationwide Children's HospitalRecruiting
- Dayton Children's - DaytonRecruiting
- Toledo HospitalRecruiting
- Tod Children's HospitalRecruiting
- Oklahoma University Cancer InstituteRecruiting
- Legacy Emanuel Children's HospitalRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Penn State Children's HospitalRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- Children's Hospital of Pittsburgh of UPMCRecruiting
- Greenville Hospital Cancer CenterRecruiting
- Avera Cancer InstituteRecruiting
- East Tennessee Children's HospitalRecruiting
- Texas Tech University Health Sciences Center School of Medicine - AmarilloRecruiting
- Driscoll Children's HospitalRecruiting
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasRecruiting
- Cook Children's Medical Center - Fort WorthRecruiting
- University of Texas Health Science Center at San AntonioRecruiting
- Methodist Children's Hospital of South TexasRecruiting
- Primary Children's Medical CenterRecruiting
- University of Virginia Cancer CenterRecruiting
- Inova Fairfax HospitalRecruiting
- Children's Hospital of The King's DaughtersRecruiting
- Children's Hospital and Regional Medical Center - SeattleRecruiting
- Providence Cancer Center at Sacred Heart Medical CenterRecruiting
- Mary Bridge Children's Hospital and Health Center - TacomaRecruiting
- West Virginia University Health Sciences Center - CharlestonRecruiting
- St. Vincent Hospital Regional Cancer CenterRecruiting
- Marshfield Clinic - Marshfield CenterRecruiting
- Midwest Children's Cancer Center at Children's Hospital of WisconsinRecruiting
- Children's Hospital at WestmeadRecruiting
- Royal Children's HospitalRecruiting
- Women's and Children's HospitalRecruiting
- Princess Margaret Hospital for ChildrenRecruiting
- University of Alberta HospitalRecruiting
- Children's and Women's Hospital of British ColumbiaRecruiting
- CancerCare ManitobaRecruiting
- Janeway Children's Health and Rehabilitation CentreRecruiting
- IWK Health CentreRecruiting
- Hospital for Sick ChildrenRecruiting
- Hopital Sainte JustineRecruiting
- Saskatoon Cancer Centre at the University of SaskatchewanRecruiting
- Centre Hospitalier Universitaire de QuebecRecruiting
- Starship Children's HealthRecruiting
- San Jorge Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group 1
Group 2, arm I
Group 2, arm II
Patients receive 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week. Some patients may then undergo surgical resection of the tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8 courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord also undergo concurrent radiotherapy.
Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive 7 additional courses of VAI chemotherapy (courses 8-14). Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days.
Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients receive autologous PBSC IV on day 0. Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks.