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

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Trial Identification

Brief Title: Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome

Official Title: A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes

Study ID: NCT00003123

Conditions

Myelodysplastic Syndromes

Interventions

amifostine trihydrate

Study Description

Brief Summary: RATIONALE: Amifostine may be effective in helping blood counts return to normal in treating patients with myelodysplastic syndrome. PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with advanced myelodysplastic syndrome.

Detailed Description: OBJECTIVES: I. Determine the overall hematologic response rate to amifostine in patients with advanced myelodysplastic syndrome. II. Determine the toxic effects of amifostine in these patients. OUTLINE: This is an open label study. Patients receive intravenous amifostine over 15 minutes three times a week. Patients failing to respond by 8 weeks undergo dose escalation. Nonresponding patients are removed from the study by 12 weeks. Therapy is continued for up to six months in responding patients. Patients are observed for duration of response upon therapy discontinuation. Patients who relapse will have therapy resumed at the previous dose. Patients will be followed until death. PROJECTED ACCRUAL: A maximum of 36 patients will be accrued.