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Phase III Chemohormonal Therapy with ADR/CCNU/VCR/FXM vs CTX/MPA plus Immunotherapy with C. parvum for Metastatic Renal Carcinoma
Basic Trial Information
Objectives I. Compare the effectiveness of 2 regimens employing a combination of cytotoxic and hormonal agents with or without immunotherapy using C. parvum in the treatment of metastatic renal carcinoma. Crossover for patients with disease progression. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with renal cell carcinoma (adenocarcinoma, hypernephroma) or unequivocal arteriographic evidence of an inoperable primary lesion. Patients must be between 20 and 70 years of age, with expected survival exceeding 2 months. Patients may not have received prior cytotoxic-agent treatment, but may have received prior hormonal therapy. Expected Enrollment Protocol closed as of October 1979; 17 patients have been entered. Outline Randomized study. Arm I: 3-Drug Combination Chemotherapy plus Hormone Therapy. Adriamycin, ADR, NSC-123127; CCNU, CCNU, NSC-79037; Vincristine, VCR, NSC-67574; plus Fluoxymesterone, FXM, NSC-12165. Arm II: Single-agent Chemotherapy plus Hormone Therapy plus Immunotherapy. Cyclophosphamide, CTX, NSC-26271; plus Medroxyprogesterone acetate, MPA, NSC-26386; plus Corynebacterium parvum, Burroughs-Wellcome, C. parvum, B.W., NSC-220537. Trial Lead Organizations Penn State Cancer Institute at Milton S. Hershey Medical Center
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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