Arsenic Trioxide and Cholecalciferol (Vitamin D) in Treating Patients With Myelodysplastic Syndromes

OBJECTIVES: Primary * Determine the complete response rate and the rate of hematological improvement in patients with myelodysplastic syndromes treated with arsenic trioxide and cholecalciferol (vitamin D). Secondary * Determine the safety of this regimen in these patients. * Determine the time to progression to acute myeloid leukemia, defined as blast ≥ 20%, in patients treated with this regimen. * Determine overall survival and progression-free survival of patients treated with this regimen. * Determine the effect of this regimen on bone marrow and peripheral blood mononuclear cell apoptosis and p21 protein expression in these patients. OUTLINE: This is an open-label, nonrandomized study. Patients receive oral cholecalciferol (vitamin D)\* once daily on days 1-28. Patients also receive arsenic trioxide IV over 1-4 hours on days 1-5 (week 1) and then twice weekly for 3 weeks (weeks 2-4) for course 1 and twice weekly for 4 weeks for all subsequent courses. Courses repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. NOTE: \* Patients who do not achieve a complete hematologic response receive escalating doses of cholecalciferol (vitamin D) at 3, 6, and 9 months during therapy in the absence of disease progression and unacceptable toxicity. At the completion of study treatment, patients are followed for survival. PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study.