A Phase II Trial of 5-Azacytidine (NSC #102816) and Ethyol (Amifostine) in the Treatment of Adults With Myelodysplastic Syndromes
OBJECTIVES: I. Determine the response rate to azacitidine plus amifostine in patients with
myelodysplastic syndromes. II. Evaluate the toxicity of this treatment regimen in these
patients. III. Assess the rate of progression to acute myeloid leukemia and overall survival
in these patients treated with this regimen. IV. Evaluate the relationship between response
status and cytogenetics, FAB class, ras mutations, and the presence of nonclonal
hematopoiesis with this treatment regimen in these patients. V. Assess the effect of this
treatment regimen on the number of bone marrow hematopoietic progenitor cells in these
patients. VI. Evaluate neutrophil adhesion and chemotaxis in these patients before and after
this treatment regimen.
OUTLINE: Patients receive amifostine IV over 1-3 minutes on days 8, 10, 12, 15, 17, 19, 22,
24, and 26 plus azacitidine subcutaneously on days 1-7. Treatment repeats every 28 days for
4 courses. Patients who achieve complete remission receive an additional 3 courses, and
patients who achieve hematologic improvement or partial remission continue treatment until
disease progression or unacceptable toxicity. Patients are followed until death.
PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study within
approximately 2 years.
Primary Purpose: Treatment
Harry P. Erba, MD, PhD
University of Michigan Cancer Center
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|