Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004161
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
1999-12-10
Brief Title:
Fenretinide in Treating Patients With Leukoplakia of the Mouth
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Randomized Double Blind Placebo-Controlled Phase II Clinical Trial of N4-Hydroxy-phenylRetinamide Fenretinide 4HPR in Oral Leukoplakia
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 Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer Fenretinide may be an effective drug in treating leukoplakia
PURPOSE Randomized phase II trial to study the effectiveness of fenretinide in treating patients who have leukoplakia of the mouth
PURPOSE Randomized phase II trial to study the effectiveness of fenretinide in treating patients who have leukoplakia of the mouth
Detailed Description:
OBJECTIVES I Determine modulation by fenretinide of surrogate endpoint markers of oral mucosal carcinogenesis in patients with oral dysplastic leukoplakia II Determine whether fenretinide will cause significant modulation of intermediate endpoint markers and significant regression of oral dysplastic leukoplakia in this patient population III Compare the ability of fenretinide and placebo to modulate surrogate endpoint biomarkers in this patient population IV Document the degree of recurrence of oral dysplastic leukoplakia after the administration of fenretinide both at the same site and at new sites
OUTLINE This is a randomized double blind placebo controlled study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive oral fenretinide daily except days 1-3 each month for 6 months Arm II Patients receive oral placebo daily except days 1-3 each month for 6 months Patients then receive oral fenretinide daily except days 1-3 each month for 6 months Patients are followed every 3 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
OUTLINE This is a randomized double blind placebo controlled study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive oral fenretinide daily except days 1-3 each month for 6 months Arm II Patients receive oral placebo daily except days 1-3 each month for 6 months Patients then receive oral fenretinide daily except days 1-3 each month for 6 months Patients are followed every 3 months
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| UAB-9713 | None | None | None |
| NCI-G99-1626 | None | None | None |