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Phase I Evaluation and Pharmacokinetic Study of Acodazole
Basic Trial Information
Objectives I. Determine the therapeutic response to acodazole in a group of patients with advanced malignancy who have no better therapeutic alternative. II. Determine the parameters and characteristics of drug toxicity, including organ-specific toxicity and characterization of toxicity by predictability, reversibility, time course, and dose-response relationships, and determine the maximum tolerated dose. III. Recommend a Phase II starting dose for this agent. IV. Determine the pharmacokinetic behavior of acodazole and correlate it with clinical data in selected patients. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients over 18 years of age with histologically proven advanced solid tumors that are refractory to all known effective therapies and investigational agents of higher potential efficacy. Patients should have near normal hepatic, renal, and bone marrow function; the life expectancy must be at least 4 weeks. Patients should have a functional capacity of 0 or 1 to be eligible to be treated at the maximum tolerated dosage. Patients must be beyond the period of expected toxicity from prior anticancer therapy; those patients who have previously received more than one Phase I or II investigational agent are eligible only with the approval of the principal investigator. Expected Enrollment 3 patients will be entered at each dose level; at least 6 patients will be treated at the MTD. Protocol temporarily closed, November 1984, due to toxicity. Protocol closed March 1985. Outline Nonrandomized Phase I study. Single-agent Chemotherapy. Acodazole, NSC-305884. Trial Lead Organizations Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University 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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