Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052611
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2003-01-24
Brief Title:
Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia andor Head and Neck Dysplasia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions A Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-03
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:
Patient at increased risk for developing a new head and neck squamous cell carcinoma are invited to take part in this study
The investigators of this trial will attempt to study the effectiveness of Celecoxib in preventing cancer in patients who have oral leukoplakia andor head and neck dysplasia
The investigators of this trial will attempt to study the effectiveness of Celecoxib in preventing cancer in patients who have oral leukoplakia andor head and neck dysplasia
Detailed Description:
Celecoxib is being studied in precancerous lesions of the head and neck in part because it has been shown to prevent the progression of another type of precancerous polyps a type of abnormal growth in patients at high risk for colorectal cancer There are however no published studies yet looking at this drug in humans for the prevention of head and neck cancers The US Food and Drug Administration has approved celecoxib for arthritis and the prevention of polyps in patients with familial adenomatous polyposis a type of precancerous syndrome in some families that can lead to colon cancer
This study is being done to find out several things
Is celecoxib also known by the trade name Celebrex effective in reducing the expression of precancerous markers biological signals for specific cellular activities in oral leukoplakia and dysplasia abnormal growth of the oral mucosa
Is celecoxib effective in reducing the size of oral leukoplalda lesions andor presence of dysplasia
Does the reduction in precancerous markers correspond with reduction of oral leukoplalda andor presence of dysplasia
What are the side effects of celecoxib in this patient population
This study is being done to find out several things
Is celecoxib also known by the trade name Celebrex effective in reducing the expression of precancerous markers biological signals for specific cellular activities in oral leukoplakia and dysplasia abnormal growth of the oral mucosa
Is celecoxib effective in reducing the size of oral leukoplalda lesions andor presence of dysplasia
Does the reduction in precancerous markers correspond with reduction of oral leukoplalda andor presence of dysplasia
What are the side effects of celecoxib in this patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| DFCI-2002-P-001502 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |
| DFCI-02024 | None | None | None |