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Phase II Pilot Immunotherapy with Intraperitoneal BCG plus Melphalan/Isoniazid Chemotherapy for Stage IC, II or III Ovarian Adenocarcinoma
Basic Trial Information
Objectives I. Evaluate the feasibility of administering intraperitoneal (ip) BCG-Tice (BCG) prior to conventional chemotherapy in patients with Stages IC, II, or III ovarian carcinoma. II. Evaluate the possible role of prior ip BCG in improving survival and frequency of response in patients receiving conventional chemotherapy for Stages IC, II, and III ovarian carcinoma. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with histologically proven stage IC, II or III adenocarcinoma of the ovary. Patients must have adequate hepatic, renal, cardiac, gastrointestinal and bone marrow function. They must have had adequate surgical staging and no prior radiation or chemotherapy. Expected Enrollment Protocol closed, July 1980. Outline Nonrandomized study. 2-Drug Combination Chemotherapy plus Immunotherapy. Melphalan, L-PAM, NSC-8806; Isoniazid, INH, NSC-9659; plus BCG-Tice, BCG, NSC-B116327. Trial Lead Organizations Eastern Cooperative 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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