EVALUATION OF AMONAFIDE IN DISSEMINATED MALIGNANT-MELANOMA - A SOUTHWEST-ONCOLOGY-GROUP STUDY

Amonafide (AMF), NSC 308847 is an investigational anticancer drug acti ng as a DNA intercalating agent. This paper presents results of a phas e II clinical study of AMF in disseminated malignant melanoma. Twenty patients, eleven males and nine females, with biopsy proven malignant melanoma, performance status 0-2; median age 59 (range 29-74), and no previous chemotherapy, were treated with AMF 300 mg/m2/day by 60 min I .V. infusion for five days repeated every three weeks. Fifteen patient s had lung (9 patients) and/or liver (8 patients) involvement. None ha d known brain metastasis at entry. All 20 patients were evaluated for response and toxicity. Six patients had stable disease and fourteen ha d increasing disease. With 0/20 responses, the upper 95% confidence li mit for the response rate was 14%. The median survival time was 5.7 mo nths. Hematologic toxicity was dose limiting with the incidence of leu copenia 45% and thrombocytopenia 20%. The nonhematologic toxicities in cluded nausea and vomiting (60%), alopecia (20%), headaches (15%), dia rrhea (10%), and phlebitis (10%). We conclude that AMF administered at this dose and schedule is not active in the treatment of patients wit h malignant melanoma, previously untreated with chemotherapy.