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Phase I Chemotherapy with Acodazole for Advanced Refractory Malignant Solid Tumors
Basic Trial Information
Objectives I. Determine the maximum tolerated dose of acodazole in patients with refractory malignancies. II. Assess the toxicity of acodazole when given intravenously every 21 days. III. Observe for antitumor activity of acodazole. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients of any age with histologically confirmed advanced malignant solid tumors that are refractory to first- or second-line chemotherapy and not amenable to surgery and/or radiotherapy, or for which no standard chemotherapy exists. Disease must be measurable or evaluable. Four weeks must have elapsed since prior radiotherapy or cytotoxic chemotherapy (6 weeks for mitomycin-C and nitrosoureas) and patients must have recovered from all toxicities of such therapy. Concomitant radiotherapy to areas of measurable disease renders these sites unevaluable for response; concomitant cranial radiotherapy for brain metastases is allowed. A performance status of 3 or better (30-100% Karnofsky) and adequate hematologic function are required. Adequate renal function defined as a BUN less than 25 mg/dl and a serum creatinine level less than 2.0 mg/dl, and adequate hepatic function defined as bilirubin less than 2.0 mg/dl and SGOT and SGPT less than 2 times the upper limits of normal, are required. (For patients with serum creatinine or total bilirubin between 2-5 mg/dl, the following eligibility criteria will be used: if 3 patients have been entered and are evaluable at a given dose level, then a patient with a serum creatinine or total bilirubin of 2-5 mg/dl may be entered at that dose level). Expected Enrollment Approximately 30 patients will be accrued. Per February 1986 notice, patient entry has been curtailed pending further study of the cardiotoxicity of Acodazole in a dog model. Outline Nonrandomized study. Single-agent Chemotherapy. Acodazole, NSC-305884. Trial Lead Organizations Barbara Ann Karmanos Cancer Institute
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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