Acute Myeloid Leukemia Clinical Trial

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Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML

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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.

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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).

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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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

87

Study ID:

NCT00195104

Recruitment Status:

Completed

Sponsor:

Weill Medical College of Cornell University

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There is 1 Location for this study

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Weill Medcial College of Cornell University
New York New York, 10021, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

87

Study ID:

NCT00195104

Recruitment Status:

Completed

Sponsor:


Weill Medical College of Cornell University

How clear is this clinincal trial information?

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