Phase I study of bisantrene in acute nonlymphoblastic leukemia.
A phase I study of bisantrene using a daily injection for 5 days was undertaken in adult patients with relapsing acute nonlymphoblastic leukemia. Seventeen patients received 27 courses, with daily doses ranging from 75 to 250 mg/m2. Although gastrointestinal toxicity and alopecia were rare, hematological toxicity occurred in 85% of the patients. There was cholestasis unrelated to infectious events in 27% of the courses, as well as reversible renal failure in eight of 27 evaluable courses. Responses (complete + partial) were obtained in 35% +/- 10% of the patients. The recommended dose for phase II study is 200 mg/m2/day X 7.
D058186:Acute Kidney Injury / Q000139:chemically induced; D000328:Adult; D000873:Anthracenes / Q000627:therapeutic use / Q000633:toxicity; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use* / Q000633:toxicity; D002779:Cholestasis / Q000139:chemically induced; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D013921:Thrombocytopenia / Q000139:chemically induced
D000873:Anthracenes; D000903:Antibiotics, Antineoplastic; C031404:bisantrene