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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Weill Medcial College of Cornell University
New York, New York, United States
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.
Time frame: 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.
Time frame: 4 weeks after the last study treatment
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.
Time frame: 4 weeks after the last study treatment
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