Arsenic Trioxide in Combination With Cytarabine in Patients With High-Risk MDS and Poor-Prognosis AML
The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.
Drug: Arsenic Trioxide (Tricenox)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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.
- To characterize the safety and tolerability of the combination of ATO and low-dose ara-C, including acute and chronic toxicities.
- To determine the CR and PR rates in patients with high-risk MDS and poor-prognosis AML treated with the combination of ATO and low-dose ara-C.
|Study Start Date:||July 2003|
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).
|United States, New York|
|Weill Medcial College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||Gail Roboz, M.D.||Weill Medical College of Cornell University|