Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299195
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2006-03-02
Brief Title:
A Randomized Study of Sulindac in Oral Premalignant Lesions
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Multi-Center International Double-Blind Placebo Controlled Randomized Study of Sulindac a Pan-Cox Inhibitor in Oral Premalignant Lesions
Status:
COMPLETED
Status Verified Date:
2020-01
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:
The purpose of this study is to see if a drug called sulindac can prevent the development of changes in the mouth that are related to oral pre-cancer growths oral epithelial dysplasia or oral cancer Sulindac is an anti-inflammatory drug that has already been tested in people with arthritis inflammation of a joint
This study is being done by Memorial Sloan-Kettering Cancer Center in New York Amrita Institute of Medical Sciences and Research Center in Cochin India and Regional Cancer Centre RCC in Trivandrum India
This study is being done by Memorial Sloan-Kettering Cancer Center in New York Amrita Institute of Medical Sciences and Research Center in Cochin India and Regional Cancer Centre RCC in Trivandrum India
Detailed Description:
Oral precancerous lesions OPL represent a valuable model for clinical trials for tobacco related cancers However due to the relatively low prevalence of this condition in the United States subject accrual to such trials is slow Conversely in India the prevalence of oral leukoplakia is among the highest in the world Indeed oral cancer caused by exposure to tobacco smoke alcohol and betel nut quid is the leading cause of cancer deaths in India
To date there are no effective treatments documented in randomized controlled clinical trials to prevent malignant transformation of leukoplakia However evidence that non-steroidal anti-inflammatory drugs NSAIDs prevent experimental and animal head and neck cancer and colon and breast cancer in humans lends support to the promise of NSAIDs in the chemoprevention of oral cancer
The purpose of this protocol is to pilot a multi-center chemoprevention trial of sulindac a pan-cyclooxygenase COX inhibitor for oral leukoplakia through an international collaboration between Memorial Sloan-Kettering Cancer Center MSKCC New York Regional Cancer Centre RCC in Trivandrum India and the Amrita Institute of Medical Sciences AIMS Kerala India Specifically we will conduct a 66 subject 2-arm double-blind placebo-controlled randomized study of sulindac 150 mg bid to test the clinical efficacy safety and molecular effects of sulindac against OPL and OPL tissue Oral leukoplakia subjects will be enrolled from both RCC AIMS and MSKCC however we expect that most subjects will be recruited from AIMS due to the substantially higher prevalence of this condition among the Indian compared to the US population
MSKCC will be the coordinating center for this trial and will thus be responsible for all aspects of clinical trial design and management Our study team in collaboration with the Office of Clinical Research and the Office of the Physician-in-Chief has spent a considerable amount of time and effort in developing a comprehensive data and safety monitoring DSM plan
To date there are no effective treatments documented in randomized controlled clinical trials to prevent malignant transformation of leukoplakia However evidence that non-steroidal anti-inflammatory drugs NSAIDs prevent experimental and animal head and neck cancer and colon and breast cancer in humans lends support to the promise of NSAIDs in the chemoprevention of oral cancer
The purpose of this protocol is to pilot a multi-center chemoprevention trial of sulindac a pan-cyclooxygenase COX inhibitor for oral leukoplakia through an international collaboration between Memorial Sloan-Kettering Cancer Center MSKCC New York Regional Cancer Centre RCC in Trivandrum India and the Amrita Institute of Medical Sciences AIMS Kerala India Specifically we will conduct a 66 subject 2-arm double-blind placebo-controlled randomized study of sulindac 150 mg bid to test the clinical efficacy safety and molecular effects of sulindac against OPL and OPL tissue Oral leukoplakia subjects will be enrolled from both RCC AIMS and MSKCC however we expect that most subjects will be recruited from AIMS due to the substantially higher prevalence of this condition among the Indian compared to the US population
MSKCC will be the coordinating center for this trial and will thus be responsible for all aspects of clinical trial design and management Our study team in collaboration with the Office of Clinical Research and the Office of the Physician-in-Chief has spent a considerable amount of time and effort in developing a comprehensive data and safety monitoring DSM plan
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