Spots Global Cancer Trial Database for Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
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Trial Identification
Brief Title: Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
Official Title: Phase I/II Study of Arsenic Trioxide in Combination With Cytosine Arabinoside in Patients With High-risk Myelodysplastic Syndrome and Poor-prognosis Acute Myelogenous Leukemia
Study ID: NCT00195104
Conditions
Study Description
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/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).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Weill Medcial College of Cornell University, New York, New York, United States
Contact Details
Name: Gail Roboz, M.D.
Affiliation: Weill Medical College of Cornell University
Role: PRINCIPAL_INVESTIGATOR
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