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
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).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of cytosine arabinoside in combination with ATO 0.25mg/kg/day IV for 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML.
Gail Roboz, M.D.
Weill Medical College of Cornell University
United States: Food and Drug Administration
|Weill Medcial College of Cornell University||New York, New York 10021|