Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome
OBJECTIVES: I. Define the activity of amifostine in improving blood counts in patients with
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Maximum Tolerated Dose (MTD) of Amifostine
Responses are evaluated after each cycle (for a minimum of 2 induction cycles).
After each 4 week cycle
Razelle Kurzrock, MD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|