Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003252
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
1999-11-01
Brief Title:
Amifostine in Treating Patients With Cancer Who Have Neurological Changes Caused by Chemotherapy
Sponsor:
Rush North Shore Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase IV Open Label Study of the Effects of a Five Minute Infusion Time for Ethyol Amifostine in Patients Undergoing Chemotherapy
Status:
COMPLETED
Status Verified Date:
2000-04
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 Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase IV trial to study the effectiveness of amifostine in treating patients with cancer who have neurological changes caused by chemotherapy
PURPOSE Phase IV trial to study the effectiveness of amifostine in treating patients with cancer who have neurological changes caused by chemotherapy
Detailed Description:
OBJECTIVES I Determine the feasibility and tolerability of administering amifostine by intravenous infusion over 5 minutes in cancer patients undergoing chemotherapy
OUTLINE This is an open label controlled study Patients receive intravenous amifostine over 5 minutes 30 minutes prior to chemotherapy Patients are followed for one month post treatment
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
OUTLINE This is an open label controlled study Patients receive intravenous amifostine over 5 minutes 30 minutes prior to chemotherapy Patients are followed for one month post treatment
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
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-V98-1390 | None | None | None |
| RNSMC-AM9702 | None | None | None |
| ALZA-RNSMC-AM9702 | None | None | None |