Acute Myeloid Leukemia Clinical Trial
Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
Summary
The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.
Full Description
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).
Eligibility Criteria
Inclusion Criteria:
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.
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There is 1 Location for this study
New York New York, 10021, United States
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