Myelodysplastic Syndromes Clinical Trial
Official title:
Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome
RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with
myelodysplastic syndrome.
OBJECTIVES: I. Define the activity of amifostine in improving blood counts in patients with
myelodysplastic syndrome.
OUTLINE: This is an open label, nonrandomized, single center, dose escalation study. Patients
receive amifostine IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4
weeks. Responses are evaluated after each cycle (for a minimum of 2 induction cycles).
Patients with a grade 0 toxicity in the first course receive a 25% increase in dose during
the second course. Patients with grade 1 or 2 toxicity receive no dose change. Patients with
grade 3 toxicity receive a 25% reduction in dose or treatment is stopped. All patients
demonstrating response are eligible for maintenance therapy. Treatment is continued for up to
12 months or a total of 13 cycles.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued.
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