Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have myelodysplastic syndromes.

OBJECTIVES: * Determine the percentage of patients with low-risk myelodysplastic syndromes (MDS) who achieve a major hematologic improvement after treatment with arsenic trioxide. * Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug. * Determine the durability of responses in patients treated with this drug. * Determine the duration of overall and progression-free survival of patients treated with this drug. * Assess the quality of life of patients treated with this drug. * Assess the toxicity profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to risk score (low risk vs high risk). Patients receive arsenic trioxide IV 5 days a week on weeks 1-2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better may receive additional courses of treatment. Patients who achieve a complete remission (CR) should receive 2 additional courses of treatment after documentation of CR. Quality of life is assessed at baseline, every 8 weeks during study, and then at 4 weeks after study completion. Patients are followed at 4 weeks, every 3 months until completion of study treatment, and then annually thereafter. PROJECTED ACCRUAL: A total of 30-110 patients (15-55 per stratum) will be accrued for this study.

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Eligibility

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