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

• Status: Completed
• Trial end date: 2006-06-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Arsenic Trioxide; Cytarabine

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.