Azacitidine Plus Amifostine in Treating Patients With Myelodysplastic Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005598|
Recruitment Status : Completed
First Posted : December 16, 2003
Last Update Posted : December 21, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Amifostine may improve blood counts in patients with myelodysplastic syndrome. Combining azacitidine with amifostine may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of azacitidine plus amifostine in treating patients who have myelodysplastic syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Drug: amifostine trihydrate Drug: azacitidine||Phase 2|
OBJECTIVES: I. Determine the response rate to azacitidine plus amifostine in patients with myelodysplastic syndromes. II. Evaluate the toxicity of this treatment regimen in these patients. III. Assess the rate of progression to acute myeloid leukemia and overall survival in these patients treated with this regimen. IV. Evaluate the relationship between response status and cytogenetics, FAB class, ras mutations, and the presence of nonclonal hematopoiesis with this treatment regimen in these patients. V. Assess the effect of this treatment regimen on the number of bone marrow hematopoietic progenitor cells in these patients. VI. Evaluate neutrophil adhesion and chemotaxis in these patients before and after this treatment regimen.
OUTLINE: Patients receive amifostine IV over 1-3 minutes on days 8, 10, 12, 15, 17, 19, 22, 24, and 26 plus azacitidine subcutaneously on days 1-7. Treatment repeats every 28 days for 4 courses. Patients who achieve complete remission receive an additional 3 courses, and patients who achieve hematologic improvement or partial remission continue treatment until disease progression or unacceptable toxicity. Patients are followed until death.
PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study within approximately 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial of 5-Azacytidine (NSC #102816) and Ethyol (Amifostine) in the Treatment of Adults With Myelodysplastic Syndromes|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||December 2001|
|Actual Study Completion Date :||March 2002|
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): NCT00005598
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0752|
|Study Chair:||Harry P. Erba, MD, PhD||University of Michigan Cancer Center|