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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
12
Escalating dose IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4 weeks.
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Maximum Tolerated Dose (MTD) of Amifostine
Responses are evaluated after each cycle (for a minimum of 2 induction cycles).
Time frame: After each 4 week cycle
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.