Initial clinical studies with bruceantin
Bedikian, A.Y.; Valdivieso, M.; Bodey, G.P.; Murphy, W.K.; Freireich, E.J.
Cancer Treatment Reports 63(11-12): 1843-1847
1979
ISSN/ISBN: 0361-5960 PMID: 526918 Document Number: 153717
A phase I clinical study of bruceantin was conducted in 66 patients with various types of advanced solid tumors to evaluate its toxicity and efficacy. The initial dose of 0.2 mg/m2 per day .times. 5 days repeated at 2 wk intervals was progressively increased to a maximum dose of 4.5 mg/m2 per day. Hypotension was the dose-limiting toxic effect; it was delayed, cumulative and occurred more often in patients with abnormal pretreatment liver function. Nausea, vomiting and fever were common at higher doses and diarrhea, stomatitis, alopecia, paresthesia and rash were observed in some patients. The hematologic toxicity of bruceantin was moderate at high doses and was manifested mainly as thrombocytopenia; it was more severe in patients with abnormal hepatic and renal functions. No objective tumor regressions were observed. The recommended dose of bruceantin is 3.5 mg/m2 per day .times. 5 days for phase II studies.