Amifostine in Treating Patients With Myelodysplastic Syndrome
- Registration Number
- NCT00003048
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Amifostine Amifostine Trihydrate Amifostine IV 2 weeks, followed by 2 weeks rest (4 week cycle)
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) of Amifostine After each 4 week cycle Responses are evaluated after each cycle (for a minimum of 2 induction cycles).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States