Expired Study
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New York, New York 10021


Purpose:

The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.


Study summary:

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).


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.


NCT ID:

NCT00195104


Primary Contact:

Principal Investigator
Gail Roboz, M.D.
Weill Medical College of Cornell University


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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