Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003123
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome
Sponsor:
Providence Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Ethyol Amifostine in Adult Patients With Advanced Myelodysplastic Syndromes
Status:
UNKNOWN
Status Verified Date:
2004-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 be effective in helping blood counts return to normal in treating patients with myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of amifostine in treating patients with advanced myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of amifostine in treating patients with advanced myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine the overall hematologic response rate to amifostine in patients with advanced myelodysplastic syndrome II Determine the toxic effects of amifostine in these patients
OUTLINE This is an open label study Patients receive intravenous amifostine over 15 minutes three times a week Patients failing to respond by 8 weeks undergo dose escalation Nonresponding patients are removed from the study by 12 weeks Therapy is continued for up to six months in responding patients Patients are observed for duration of response upon therapy discontinuation Patients who relapse will have therapy resumed at the previous dose Patients will be followed until death
PROJECTED ACCRUAL A maximum of 36 patients will be accrued
OUTLINE This is an open label study Patients receive intravenous amifostine over 15 minutes three times a week Patients failing to respond by 8 weeks undergo dose escalation Nonresponding patients are removed from the study by 12 weeks Therapy is continued for up to six months in responding patients Patients are observed for duration of response upon therapy discontinuation Patients who relapse will have therapy resumed at the previous dose Patients will be followed until death
PROJECTED ACCRUAL A maximum of 36 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 |
|---|---|---|---|
| NCI-V97-1350 | None | None | None |
| PH-890 | None | None | None |
| ALZA-97-018-ii | None | None | None |