Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004154
Status:
COMPLETED
Last Update Posted:
2018-11-08
First Post:
1999-12-10
Brief Title:
Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Randomized Chemoprevention Trial With 4-HPR Fenretinide in Superficial Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2018-11
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 such as fenretinide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing It is not yet known whether fenretinide is more effective than a placebo in preventing the recurrence of bladder cancer after surgery to remove the tumor
PURPOSE This randomized phase III trial is studying fenretinide to see how well it works compared to a placebo in treating patients who are at risk for recurrent bladder cancer following surgery to remove the tumor
PURPOSE This randomized phase III trial is studying fenretinide to see how well it works compared to a placebo in treating patients who are at risk for recurrent bladder cancer following surgery to remove the tumor
Detailed Description:
OBJECTIVES
Determine the efficacy mechanism of action and toxicity of fenretinide in patients at risk of recurrent superficial bladder cancer after complete resection of initial tumor
Determine the treatment effects in modulating the expression of retinoid receptors chromosomal abnormalities numerical chromosomal abnormalities and DNA ploidy apoptosis and autocrine motility factor receptor intermediate endpoint markers of recurrent disease in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to lesion type multifocal vs solitary Patients are randomized to one of two treatment arms
Patients receive either oral fenretinide or placebo on days 1-25 Courses repeat every 28 days for up to 1 year in the absence of disease progression unacceptable toxicity or development of a second primary cancer requiring therapy
Patients are followed every 3 months for 15 months
PROJECTED ACCRUAL A total of 178 patients 89 per arm will be accrued for this study
Determine the efficacy mechanism of action and toxicity of fenretinide in patients at risk of recurrent superficial bladder cancer after complete resection of initial tumor
Determine the treatment effects in modulating the expression of retinoid receptors chromosomal abnormalities numerical chromosomal abnormalities and DNA ploidy apoptosis and autocrine motility factor receptor intermediate endpoint markers of recurrent disease in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to lesion type multifocal vs solitary Patients are randomized to one of two treatment arms
Patients receive either oral fenretinide or placebo on days 1-25 Courses repeat every 28 days for up to 1 year in the absence of disease progression unacceptable toxicity or development of a second primary cancer requiring therapy
Patients are followed every 3 months for 15 months
PROJECTED ACCRUAL A total of 178 patients 89 per arm 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 |
|---|---|---|---|
| MDA-ID-95236 | None | None | None |
| NCI-G99-1621 | None | None | None |
| NCI-T98-0051 | None | None | None |
| ID95-236 | OTHER | UT MD Anderson Cancer Center | None |