Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005598
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2000-05-02
Brief Title:
Azacitidine Plus Amifostine in Treating Patients With Myelodysplastic Syndrome
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
A Phase II Trial of 5-Azacytidine NSC 102816 and Ethyol Amifostine in the Treatment of Adults With Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase II trial to study the effectiveness of azacitidine plus amifostine in treating patients who have myelodysplastic syndrome
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T99-0069 | Other Identifier | University of Michigan Cancer Center PRC | httpsreporternihgovquickSearchP30CA046592 |
| P30CA046592 | NIH | None | None |
| CCUM-9906 | OTHER | None | None |