PHASE-I TRIAL OF BRUCEANTIN

Abstract

Bruceantin was administered to 33 patients with advanced solid tumors or hematologic neoplasms. The schedule consisted of 4 weekly i.v. injections at 1 dose level followed by a 2 wk no-treatment period; this program was repeated every 6 wk. A total of 156 weekly injections was given over a dose range of 0.8-8.5 mg/m2. Systolic and diastolic hypotension was dose-related and dose-limiting at a level of .gtoreq. 6.0 mg/m2; transient febrile reactions were dose-related. Gastrointestinal toxicity was commonly observed but was not dose-limiting. There was no hematologic or renal toxicity; hepatic toxicity was subclinical and reversible. Eighteen patients were evaluable for antitumor response including 1 patient with adenocarcinoma of the cervix who experienced a < 50% disease regression lasting 10 mo. and 1 patient with pleural mesothelioma who experienced disease stabilization lasting 4 mo. A phase II study of bruceantin is recommended at a starting dose of 5.5 mg/m2 weekly for 4 wk as a 4 h i.v. infusion repeated at 6 wk intervals.