Status:
COMPLETED
Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed 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/d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 17 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2006
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00195104
Start Date
September 17 2003
End Date
June 20 2006
Last Update
March 3 2017
Active Locations (1)
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1
Weill Medcial College of Cornell University
New York, New York, United States, 10021