Combination Chemotherapy With or Without Topotecan in Treating Patients With Newly Diagnosed Localized 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
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically and cytologically confirmed extracranial Ewing's sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue Chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology, or ipsilateral pleural-based secondary tumor nodules allowed Contralateral pleural effusions or pleural nodules are not eligible Tumor arising in the bony skull (extradural) are eligible Tumors arising in the intradural soft tissue are not eligible Newly diagnosed disease Only have had a biopsy of the primary tumor without an attempt at complete or partial resection Prior attempted or accomplished unplanned excision allowed provided adequate imaging was obtained prior to surgery AND resection considered incomplete and further local control required No evidence of metastatic disease, defined as lesions discontinuous from the primary tumor, are not regional lymph nodes, and do not share a body cavity with the primary tumor No evidence of metastatic lung disease by CT scan One pulmonary nodule > 1 cm in diameter OR > 1 nodule > 0.5 cm in diameter are considered evidence of pulmonary metastasis Solitary nodules 0.5-1.0 cm or multiple nodules 0.3-0.5 cm must be confirmed negative by biopsy Solitary nodules < 0.5 cm or multiple nodules < 0.3 cm not considered clear evidence of lung disease No distant nodule disease No esthesioneuroblastoma PATIENT CHARACTERISTICS: Performance status (PS) 0-2 (Karnofsky PS 50-100% for patients ≥ 16 years of age or Lansky PS 50-100% for patients < 16 years of age) Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST or ALT < 2.5 times ULN Shortening fraction ≥ 27% by EKG Ejection fraction ≥ 50% by radionuclide angiogram Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiotherapy No prior chemotherapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I
Arm II
Patients receive vincristine sulfate IV over 1 minute once a week on day 1 in weeks 1-3, 7-9, and 13-15; doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 1, 7, and 13; cyclophosphamide IV over 1 hour on day 1 in weeks 1, 7, and 13; and ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4, 10, and 16. Patients undergo local therapy comprising conventional surgery (surgical resection) in approximately week 18 and/or radiation therapy beginning in approximately week 19.
Patients receive vincristine sulfate IV over 1 minute once a week on day 1 in weeks 1-3, 7-9, and 13-16; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 13; cyclophosphamide IV over 30 minutes on days 1-5 in weeks 1 and 13 and IV over 1 hour on day 1 in weeks 7 and 16; ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4 and 10; and doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 7 and 16. Patients also undergo local therapy comprising of conventional surgery (surgical resection) in approximately week 18 and/or radiation therapy beginning in approximately week 19. Patients then proceed to combination chemotherapy.