Phase I trial of laromustine in combination with infusional ara-C in elderly patients over age 60 with newly diagnosed AML or high-grade MDS

7054 Background: Laromustine is a novel sulfonylhydrazine-alkylating agent with activity in acute myeloid leukemia (AML). In vitro combinations of laromustine and cytarabine (ara-C) show synergistic cytotoxicity. Laromustine in phase I and II trials shows activity in patients with relapsed/refractory leukemia (1) and elderly patients with new AML (2). Major toxicites include infusion reactions, myelosuppression, and febrile neutropenia. Older patients had a CR rate on phase II trial of 31% (2). Based on this data, a phase I study to evaluate the safety and efficacy of combining escalating doses of laromustine with infusional ara-C in AML and MDS patients over 60. Comprehensive geriatric assessments (CGA) are performed as part of the study. Methods: Laromustine 300 mg/m2 (cohort 1, n = 6), 400 mg/m2 (cohort 2, n = 5) and 500 mg/m2 (cohort 3) was administered by IV infusion over 1 hour on day 1 in combination with ara-C 100 mg/m2/day as a continuous infusion for 7 days. Patients achieving CR after induction...