Phase I trial of bruceantin.
Bruceantin was administered to 33 patients with advanced solid tumors or hematologic neoplasms. The schedule consisted of four weekly iv injections at one dose level followed by a 2-week "no-treatment" period; this program was repeated every 6 weeks. A total of 156 weekly injections were given over a dose range of 0.8-8.5 mg/m2. Systolic and diastolic hypotension was dose-related and dose-limiting at doses of greater than or equal to 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. Of 18 patients evaluable for antitumor response one patient with adenocarcinoma of the cervix experienced a less than 50% disease regression lasting 10 months and one patient with pleural mesothelioma experienced disease stabilization lasting 4 months. A phase II study of bruceantin is recommended at a starting dose of 5.5 mg/m2 weekly for 4 weeks as a 4-hour iv infusion repeated at 6-week intervals.
D000230:Adenocarcinoma / Q000188:drug therapy; D000293:Adolescent; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D002648:Child; D002675:Child, Preschool; D004064:Digestive System / Q000187:drug effects; D004341:Drug Evaluation; D005260:Female; D005334:Fever / Q000139:chemically induced; D005900:Glaucarubin / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use* / Q000633:toxicity; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D008099:Liver / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D011714:Pyrans / Q000627:therapeutic use*; D036702:Quassins; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy
D000972:Antineoplastic Agents, Phytogenic; D011714:Pyrans; D036702:Quassins; D005900:Glaucarubin; C002550:bruceantin