Amifostine in Treating Patients With Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00003048|
Recruitment Status : Completed
First Posted : September 6, 2004
Last Update Posted : July 30, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Drug: Amifostine Trihydrate||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome|
|Study Start Date :||May 1997|
|Actual Primary Completion Date :||February 2001|
|Actual Study Completion Date :||February 2001|
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.
- Maximum Tolerated Dose (MTD) of Amifostine [ Time Frame: After each 4 week cycle ]Responses are evaluated after each cycle (for a minimum of 2 induction cycles).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|