Myelodysplastic Syndrome Clinical Trial
Official title:
Phase I/II Study of Arsenic Trioxide in Combination With Cytosine Arabinoside in Patients With High-risk Myelodysplastic Syndrome and Poor-prognosis Acute Myelogenous Leukemia
The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.
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).
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