This is an open-label, single institution, dose-escalation study of low-dose cytosine arabinoside and arsenic trioxide.
Patients will receive a fixed dose of arsenic trioxide administered 0.25mg/kg/day on days 1-5 and 8-12 and ara-C administered at 5, 7.5, or 10 mg/m2 SC BID days 1-14 in repeated cycles of 2 weeks on therapy and 2 weeks off therapy in a standard dose escalation design (1 cycle = 2 weeks on therapy + 2 weeks off therapy).
Histologic diagnosis of high-risk MDS (IPSS int-2). No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine).
Exclusion Criteria:
Pregnant or lactating women. Absolute QT interval >460 msec in the presence of serum potassium and magnesium values within the normal range. Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents. Uncontrolled or severe cardiovascular or pulmonary disease.