Leukemia Clinical Trial
Official title:
Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
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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