Clinical and clinical pharmacologic studies of mitoxantrone
Stewart, J.A.; McCormack, J.J.; Krakoff, I.H.
Cancer Treatment Reports 66(6): 1327-1331
1982
ISSN/ISBN: 0361-5960 PMID: 7083236 Document Number: 182678
The drug mitoxantrone was given to 31 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.