PHASE-I TRIAL OF VINDESINE IN PATIENTS WITH ADVANCED CANCER

Abstract

A phase I evaluation of vindesine was carried out in 69 adult patients with advanced malignancies. Two escalating dose schedules were explored: a single dose every 7-14 days, and daily injections .times. 5-10 days as tolerated. The main toxic effects were myelosuppression, alopecia, paresthesia, asthenia, myalgia and hyporeflexia. Antitumor activity was seen during this phase I study in patients with leukemia, lymphoma, and testicular neoplasms. Disease oriented phase II trials of 3-4 mg/m2 every 7-14 days or 1.3-2.0 mg/m2 per day .times. 5-7 days every 3 wk would be appropriate.