Phase I study of mitoxantrone on a daily X 5 schedule.

Mitoxantrone (NSC-301739) is a synthetic amino anthraquinone DNA intercalater active in several experimental tumor systems. Thirty-three patients with advanced cancer received the drug on a daily X 5 schedule. Myelosuppression, especially leukopenia, was the dose-limiting toxicity and was reversible. Nausea and vomiting occurred sporadically. No definite hepatic, renal, or cardiac toxicities were noted. The recommended dose for phase II evaluation in solid tumor patients with little or no prior therapy is 4.2 mg/m2/day X 5. Patients with prior myelosuppressive therapy but adequate bone marrow reserve may be started at 2.6 mg/m2/day X 5.