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Phase III Chemotherapy with ADR and with Combinations of ACT-D, L-PAM, VCR and CYL for Soft Tissue and Osseous Sarcomas (Summary Last Modified 10/97)
Basic Trial Information
Objectives I. Evaluate the tumor response to Single-agent Chemotherapy with adriamycin (ADR) and to combination chemotherapies with actinomycin-D/melphalan (ACT-D/L-PAM) with and without vincristine (VCR) and cycloleucine (CYL) in patients with sarcomas of mesenchymal origins. II. Evaluate cross-over to combination therapies upon progression in patients treated with ADR only, and cross-over to ADR therapy for patients not responsive to combination chemotherapy. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients between 16 and 80 years of age with measurable incurable sarcomas including soft-tissue sarcomas (liposarcoma, rhabdomyosarcoma, synovial and fibrosarcoma) and bone and cartilage sarcomas (osteogenic sarcoma, chondrosarcoma and Ewing's sarcoma) as well as sarcomas of undetermined histiogenesis. Patients must have adequate hematological, hepatic and renal functions, with CPK less than 120% of the upper value of the normal range and a life expectancy of at least 3 months. Expected Enrollment Protocol closed 10/75. Outline Randomized Study. Induction and Maintenance. Arm I: 2-Drug Combination Chemotherapy. Actinomycin-D, ACT-D, NSC-3053; Melphalan, L-PAM, NSC-8806. Arm II: 3-Drug Combination Chemotherapy. ACT-D, L-PAM, plus Vincristine, VCR, NSC-67574. Arm III: 3-Drug Combination Chemotherapy. ACT-D, L-PAM, plus cycloleucine, CYL, NSC-1026. Arm IV: Single-agent Chemotherapy. Adriamycin, ADR, NSC-123127. Trial Lead Organizations Central Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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