Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011973
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2001-03-03
Brief Title:
Chemotherapy in Treating Patients With Advanced Kidney Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
A Phase Two Study Of Fenretinide In Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2013-04
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
PURPOSE Phase II trial to study the effectiveness of fenretinide in treating patients who have advanced kidney cancer
PURPOSE Phase II trial to study the effectiveness of fenretinide in treating patients who have advanced kidney cancer
Detailed Description:
OBJECTIVES
Determine the response rate of patients with advanced renal cell carcinoma treated with fenretinide
Determine progression-free and overall survival of this patient population treated with this drug
Determine the quantitative and qualitative toxic effects of this drug in these patients
OUTLINE Patients receive oral fenretinide twice a day for 7 days Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL Approximately 18-35 patients will be accrued for this study within 9-21 months
Determine the response rate of patients with advanced renal cell carcinoma treated with fenretinide
Determine progression-free and overall survival of this patient population treated with this drug
Determine the quantitative and qualitative toxic effects of this drug in these patients
OUTLINE Patients receive oral fenretinide twice a day for 7 days Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL Approximately 18-35 patients will be accrued for this study within 9-21 months
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-WSU-910 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| U01CA062487 | NIH | None | None |
| P30CA022453 | NIH | None | None |
| WSU-C-2232 | None | None | None |