PILOT-STUDY OF 5-AZACYTIDINE (5-AZA) AND CARBOPLATIN (CBDCA) IN PATIENTS WITH RELAPSED REFRACTORY LEUKEMIA/

5-azacytidine (B-AZA) and carboplatin (CBDCA) are two agents which hav e demonstrated antileukemic activity in a number of phase I-II trials. Their mechanisms of action and pharmacology related to cell resistanc e suggested suitability for combination therapy. The aim of this pilot study was to evaluate the effects of this combination in the treatmen t of patients with relapsed/refractory acute leukemia. A total of 21 p atients was enrolled. 5-azacytidine, at doses ranging from 50-150 mg/m (2)/day, was administered as a 2-hr infusion for 5 consecutive days. O n day 3, patients began a B-day course of CBDCA given as a 24-hr conti nuous intravenous infusion of 250 mg/m(2)/day. There were no complete remissions with this regimen. Although there were three partial respon ses, these were generally of short duration, Nonhematologic toxicities were mild. No correlation was seen between response and serum platinu m levels. These results demonstrate that the 5-AZA/CBDCA combination i s ineffective therapy for heavily pretreated patients with acute leuke mia. (C) 1996 Wiley-Liss, Inc.