Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003048
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
1999-11-01
Brief Title:
Amifostine in Treating Patients With Myelodysplastic Syndrome
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2018-10
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 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
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
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 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 |
|---|---|---|---|
| CDR0000065687 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-97-041 | OTHER | None | None |
| ALZA-97-007-ii | None | None | None |
| ALZA-MDA-DM-97-041 | None | None | None |
| NCI-V97-1300 | None | None | None |