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Phase II Chemotherapy with L-Alanosine for Patients with Metastatic Carcinoma of the Breast Refractory to Standard Therapy
Basic Trial Information
Objectives I. Determine the response rate and duration of response among patients with metastatic refractory breast carcinoma treated with L-alanosine on a 3-day q 3 weeks schedule. II. Determine the nature and degree of toxicity of L-alanosine in these patients. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with measurable or evaluable metastatic carcinoma of the breast resistant to standard therapy and not eligible for higher priority SWOG protocols. The life expectancy must be at least 9 weeks and the performance status 2 or better, with the exception that patients with a functional class of 3 due to bone pain only will be eligible. Liver, kidney, and bone marrow function must be adequate, and patients must have recovered from the acute toxicities of any previous therapy. Radiotherapy may be given concomitantly to painful areas, brain metastases, or lytic bone lesions in danger of fracture provided large areas of bone marrow or the measurable lesions are not irradiated. Expected Enrollment If there is a response among any of the first 14 evaluable patients in each of the two prior chemotherapy stratification groups, accrual will be continued to 30-40 evaluable patients in that group. Protocol closed May 1984 with accrual objectives met. Outline Nonrandomized study. Single-agent Chemotherapy. L-Alanosine, NSC-153353.Published Results Von Hoff DD, Green SJ, Neidhart JA, et al.: Phase II study of l-alanosine (NSC 153353) in patients with advanced breast cancer: a Southwest Oncology Group study. Invest New Drugs 9(1): 87-88, 1991. Trial Lead Organizations Southwest 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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