Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes
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.
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.
;
Primary Purpose: Treatment
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