Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)

Study Overview
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Brief Summary
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In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule. Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.

Official Title
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A Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)

Conditions
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Myelodysplastic Syndrome (MDS)

Intervention / Treatment
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* Drug: Arsenic Trioxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Myelodysplastic Syndrome by FAB. Can be made with cytogenetic analysis of Bone Marrow or Hematologist evaluation Patient must have had bone marrow biopsy and aspiration to confirm diagnosis within 60 days prior to treatment ECOG performance status of 0-2 An EKG must be performed within 7 days prior to treatment to confirm QT interval <460msec. Serum creatinine less than or equal to 2.5 times the upper limit of normal. Serum bilirubin less than or equal to 2.5 times the upper limit of normal. Serum potassium greater than or equal to 4.0 mEq/dL and serum magnesium greater than or equal to 1.8 mg/dL. If these serum electrolytes are below the specified limits on the baseline laboratory tests, electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide. Patients must be 18 years of age to participate in this study Exclusion Criteria: Pregnant or nursing women, and men or women of childbearing potential who are unwilling to employ adequate contraception. Corrected QT interval of greater than or equal to 460msec in the presence of serum potassium and magnesium values within normal range. Significant CHF, coronary is ischemia or serious Arrhythmias including conduction delays. Peripheral neuropathy greater than or equal to 2. Evidence of active infection Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents. Inability or unwillingness to comply with the treatment protocol, follow up, or research tests.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Arsenic Trioxide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |