Spots Global Cancer Trial Database for Amifostine in Treating Patients With Myelodysplastic Syndrome

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Trial Identification

Brief Title: Amifostine in Treating Patients With Myelodysplastic Syndrome

Official Title: Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome

Study ID: NCT00003048

Conditions

Myelodysplastic Syndromes

Interventions

Amifostine Trihydrate

Study Description

Brief Summary: 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.

Detailed Description: 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.