Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025051
Status:
WITHDRAWN
Last Update Posted:
2013-03-22
First Post:
2001-10-11
Brief Title:
Celecoxib in Preventing Skin Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Double-Blind Placebo-Controlled Clinical Trial To Assess Celecoxib As A Chemopreventive Agent Inhibiting UV-Induced Erythema And Cutaneous Carcinogenesis As Assessed Through Surrogate Biological Markers In Biopsied Skin After Exposure Of Skin In Normal Volunteers Ages 20-60 Years Old With Fitzpatrick Type I II III And IV Skin To UV-Radiation From Artificial Light Sources
Status:
WITHDRAWN
Status Verified Date:
2006-12
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 Celecoxib may be effective in preventing skin cancer by decreasing redness caused by exposure to ultraviolet light and changing potential skin cancer biomarkers It is not yet known whether celecoxib is more effective than a placebo in preventing skin cancer
PURPOSE Randomized phase II trial to study the effectiveness of celecoxib in preventing skin cancer in participants exposed to ultraviolet light
PURPOSE Randomized phase II trial to study the effectiveness of celecoxib in preventing skin cancer in participants exposed to ultraviolet light
Detailed Description:
OBJECTIVES
Determine whether celecoxib decreases ultravioletUV-induced erythema and affects surrogate biomarkers of potential neoplastic change in participants with Fitzpatrick type I-IV skin exposed to UV light
OUTLINE This is a randomized double-blind placebo-controlled study Participants are randomized to one of two treatment arms
Arm I Participants receive oral celecoxib twice daily for approximately 120 days
Arm II Participants receive oral placebo twice daily for approximately 120 days
Skin biopsies of UV-exposed sites are evaluated
Participants are followed for up to 5 weeks post-treatment
PROJECTED ACCRUAL A total of 36 participants 18 per arm will be accrued for this study within 8 months
Determine whether celecoxib decreases ultravioletUV-induced erythema and affects surrogate biomarkers of potential neoplastic change in participants with Fitzpatrick type I-IV skin exposed to UV light
OUTLINE This is a randomized double-blind placebo-controlled study Participants are randomized to one of two treatment arms
Arm I Participants receive oral celecoxib twice daily for approximately 120 days
Arm II Participants receive oral placebo twice daily for approximately 120 days
Skin biopsies of UV-exposed sites are evaluated
Participants are followed for up to 5 weeks post-treatment
PROJECTED ACCRUAL A total of 36 participants 18 per arm will be accrued for this study within 8 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPMC-U19-CA81888-01-UV | None | None | None |
| CPMC-IRB-9923 | None | None | None |
| NCI-P01-0191 | None | None | None |