[Phase II study of mitoxantrone]

A phase II clinical trial of an anthraquinone, mitoxantrone was performed in a total of 31 patients with various advanced solid tumors and 2 patients with malignant lymphomas refractory to extensive prior chemotherapies. Mitoxantrone was administered at dosages of 2 to 4 mg/m2 with a 5-day schedule or 6 to 12 mg/m2 with a one day schedule, repeating at 4-week intervals. Of 18 evaluable patients with breast cancer, one out of 2 patients who had not been exposed to regimens containing adriamycin achieved partial response lasting 3.6 months, while the remaining 16 patients exposed to adriamycin did not respond. Leukopenia less than 4 X 10(3)/cm3 and thrombocytopenia less than 100 X 10(3)/cm3 were observed in 100% and 55% of cases, respectively. Nausea and vomiting were observed in 36% of cases. Diarrhea, pyrexia, liver damage, mucositis and palpitation were observed in one case each. No ECG abnormality was recorded.