Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma
Adult Malignant Mesenchymoma, Adult Rhabdomyosarcoma, Alveolar Childhood Rhabdomyosarcoma
About this trial
This is an interventional treatment trial for Adult Malignant Mesenchymoma
Eligibility Criteria
Inclusion Criteria: Histologically proven disease of any of the following types: Non metastatic alveolar rhabdomyosarcoma Stage I, II, or III; Clinical Group I, II, or III Stage II or III, Clinical Group III embryonal rhabdomyosarcoma Botryoid Spindle cell Under 10 years, stage IV, Clinical Group IV embryonal rhabdomyosarcoma Botryoid Spindle cell Undifferentiated sarcoma Stage I, II, or III; Clinical Group I, II, or III Ectomesenchymoma Stage I, II, or III; Clinical Group I, II, or III, with alveolar features Under 10 years, Stage IV, Clinical Group IV, with embryonal features No more than 6 weeks since initial surgical procedure (e.g., biopsy) giving the definitive diagnosis No parameningeal rhabdomyosarcoma with positive CSF cytology or multiple intracranial metastases Bilirubin no greater than 1.5 mg/dL Creatinine normal* for age Not pregnant or nursing Fertile patients must use effective contraception No prior chemotherapy Prior steroids allowed No prior radiotherapy See Disease Characteristics
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Vincristine sulfate IV once a wk on wks 0-12, 15, 18-24, 27, 30-36, and 39. Dactinomycin IV once a wk on wks 0, 3, 6, 9, 12, 21, 24, 27, 30, 33, 36, and 39. Cyclophosphamide IV once a wk on wks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, and 39. After 12 weeks of chemotherapy, depending on tumor shrinkage, pts may undergo surgery. After recovery from therapeutic conventional surgery, patients receive radiation therapy once a day, 5 days a wk, during wks 12-18. For pt receiving radiotherapy during wks 0-6, dactinomycin is omitted during wks 3 and 6 and during wks 15 and 18. For patients receiving radiotherapy during wks 12-18, dactinomycin is omitted during wks 15 and 18. Patients with adequate response at wk 24 continue chemotherapy during wks 24-39. All pts receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year, until hematopoietic recovery.
Patients receive treatment as in arm I, except dactinomycin is replaced with topotecan hydrochloride IV over 15-30 minutes daily for 5 days during weeks 3, 9, 21, 27, 33, and 39. All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year, until hematopoietic recovery.