Amifostine in Treating Patients With Myelodysplastic Syndrome
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome|
- Maximum Tolerated Dose (MTD) of Amifostine [ Time Frame: After each 4 week cycle ] [ Designated as safety issue: No ]Responses are evaluated after each cycle (for a minimum of 2 induction cycles).
|Study Start Date:||May 1997|
|Study Completion Date:||February 2001|
|Primary Completion Date:||February 2001 (Final data collection date for primary outcome measure)|
Amifostine IV 2 weeks, followed by 2 weeks rest (4 week cycle)
Drug: Amifostine Trihydrate
Escalating dose IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003048
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Razelle Kurzrock, MD||M.D. Anderson Cancer Center|