RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer.

Condition	Treatment or Intervention	Phase
small cell bone sarcoma metastatic tumors of the Ewing's family nonmetastatic childhood soft tissue sarcoma localized osteosarcoma stage III adult soft tissue sarcoma stage IVA adult soft tissue sarcoma localized tumors of the Ewing's family desmoplastic small round-cell tumor stage IVB adult soft tissue sarcoma stage III Wilms' tumor metastatic childhood soft tissue sarcoma stage IV Wilms' tumor metastatic osteosarcoma	Drug: cyclophosphamide  Drug: doxorubicin  Drug: etoposide  Drug: ifosfamide  Drug: vincristine	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the response rate and event-free survival of patients with peripheral neuroectodermal tumors (PNET) and Ewing's sarcoma (ES) treated with the P6 regimen (cyclophosphamide/doxorubicin/vincristine plus etoposide/ifosfamide) with surgery (if possible) followed by radiotherapy. II. Assess response to a uniform treatment regimen so as to clarify whether PNET and ES carry a different prognosis. III. Carry out comprehensive laboratory studies in order to identify biological prognostic factors and to elucidate the biological relationship between PNET and ES.

PROTOCOL OUTLINE: Regimen A is given for courses 1, 2, 3, and 6 and Regimen B for courses 4, 5, and 7. Surgery is performed as feasible, and Radiotherapy is administered to all patients following chemotherapy, regardless of response. Regimen A: 3-Drug Combination Chemotherapy with Urothelial Protection. Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; Vincristine, VCR, NSC-67574; with Mesna, NSC-113891. Regimen B: 2-Drug Combination Chemotherapy with Urothelial Protection. Etoposide, VP-16, NSC-141540; Ifosfamide, IFF, NSC-109724; with Mesna. Surgery. Tumor resection. Radiotherapy. Irradiation of the primary tumor site using megavoltage equipment.

PROJECTED ACCRUAL: This study is conducted as two Phase II trials, one for patients with PNET and one for those with ES (it is expected that only a small number of patients with other diagnoses will be included). A maximum of 25 patients will be studied over a 3-year period in each of the two trials. If at any time on either trial more than 6 patients relapse or die of toxicity within 24 months of diagnosis, that trial will be terminated. It is anticipated that 10 patients/year from each disease category will be entered.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Patients of any age with a diagnosis confirmed by the Department of Pathology at MSKCC of one of the following entities: peripheral neuroectodermal tumors (including peripheral neuroepithelioma, Askin tumor, and adult or peripheral neuroblastoma); localized or metastatic Ewing's sarcoma; unresectable or metastatic small cell osteosarcoma; other nonrhabdomyosarcomatous soft-tissue sarcomas that are unresectable or metastatic; Wilms' tumor (metastatic or non-metastatic); desmoplastic small round-cell tumor; or other non-osteosarcomatous bone sarcomas that are unresectable or metastatic.
• Immunocytochemistry, electron microscopy, and/or chromosomal analysis may be required to rule out other small round cell neoplasms

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Brian H. Kushner,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000076464; MSKCC-90062; NCI-V90-0126; NYU-97-6
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002466
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08