A PHASE-II STUDY OF MENOGARIL (7R-O-METHYLNOGAROL) IN PATIENTS WITH RELAPSED REFRACTORY ACUTE MYELOID-LEUKEMIA - A STUDY OF THE EASTERN-COOPERATIVE-ONCOLOGY-GROUP/

Fifty-one patients (47 evaluable) with AML, 27 in first relapse and 20 either in second relapse or refractory were treated with menogaril, 1 00 mg/m(2)/day as a 90-min infusion daily for 5 days. The complete res ponse (CR) rate was 17% (8/47), and there was one partial response. Se ven of eight responders were in first relapse with a 26% response rate among first relapse patients (7/27). The median duration of survival was 3 months for all first relapse patients and 4.3 months for all oth er patients. Toxicity included grades 3-4 pancytopenia and fever (100% of patients) and grades 3-4 stomatitis and hepatic enzyme elevation ( 25% of patients). Grades 3-4 cardiac toxicity occurred in three patien ts (two grade 3 arrhythmias and one heart block). All had previously r eceived anthracyclines. Remission duration was 1.6-48+ months; two pat ients underwent bone marrow transplantation and continue in CR at 36and 48+ months. The nontransplanted patients remained in CR 1.6, 2.0, 3, 7, 14 and 27 months. Activity and toxicity of menogaril in this stu dy were comparable to that of other clinically useful anthracyclines i n AML. Further investigation of this agent in AML is warranted.