CLINICAL AND CLINICAL PHARMACOLOGIC STUDIES OF MITOXANTRONE

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  • 1 January 1982
    • journal article
    • research article
    • Vol. 66  (6) , 1327-1331
Abstract
The drug mitoxantrone was given to 31 [cancer] patients in a phase I clinical trial. The schedule of administration was once weekly for 3 wk followed by 3 wk of observation before further treatment. Dose range was from 1.5-6 mg/m2. Leukopenia was the dose-limiting toxic effect; thrombocytopenia was mild. Partial alopecia occurred in 4 of 12 patients evaluable for hair loss. Pharmacokinetic studies employing a fluorometric assay based on DNA binding measured by displacement of ethidium bromide revealed a first-phase half-life of .apprx. 15 min, with a prolonged subsequent phase. A dose of 6 mg/m2 per week .times. 3 was well-tolerated in patients not heavily pretreated with myelosuppressive therapy. Only minor clinical activity was seen with mitoxantrone.