Status:
COMPLETED
A Randomized Study of Sulindac in Oral Premalignant Lesions
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
AIMS Institute
Weill Medical College of Cornell University
Conditions:
Leukoplakia, Oral
Benign Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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, subjec...
Eligibility Criteria
Inclusion
- For this study an Oral Premalignant Lesions (OPL) is defined as a lesion which can include atypical hyperplasia, atypical hyperkeratosis, leukoplakia, and erythroplakia/erythro-leukoplakia. Histology MUST be confirmed by an MSKCC pathologist for all participating sites. An OPL may be located in the oral cavity, oropharynx.
- The subj has a histologically suspected or confirmed index oral premalignant lesion, 12mm or greater in size that has not been bx'd in the past 6 wks. Each index lesion must be either:
- An EARLY premalignant lesion defined to be at high risk as indicated by the presence of at least one of the following: atypical cells or mild dysplasia, or hyperplastic leukoplakia of high-risk sites, lateral and ventral tongue and floor or mouth OR
- An ADVANCED premalignant lesion defined as the presence of at least one of the following: moderate dysplasia or severe dysplasia (excluding CIS)
- The subj is \> 18 yrs of age
- The subj's life expectancy is \> 12 wks and Zubrod performance status is 0 or 1 (Appendix VIII).
- The subj meets the following lab eligibility criteria during a time not to exceed 4 wks prior to randomization.
- Hemoglobin level above 10g/dL for women and above 12g/dL for men.
- WBC count \> 3,000 uL.
- Platelets count \> 125,000 uL.
- Total bilirubin \< or = 1.5xULN
- AST (SGOT) and ALT (SGPT) \< or = 2.5 x ULN.
- BUN and serum creatinine \< or = 1.5 x ULN.
- If the subj is female and of childbearing potential (women are considered not of childbearing potential if they are at least 2 yrs postmenopausal and/or surgically sterile), she:
- has been using adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since her last menses and will use adequate contraception during the study, AND
- is not lactating, AND
- has a documented negative serum pregnancy test within 14 ds prior to randomization.
- The subj's history/use of NSAIDs, aspirin, corticosteroids meets the following criteria:
- total oral/intravenous corticosteroid use has been \< 14 ds within 6 mos of the Baseline visit, and
- total inhaled corticosteroid use has been \< 30 ds within 6 mos of the Baseline visit, and
- is willing to limit aspirin use to \< or = 120 mg po per d (typical cardioprotective dose in India) or \< or = 80 mg po per d (typical cardioprotective dose in the US) for the duration of the study, and is willing to abstain from chronic use of all NSAIDs and COX-2 inhibitors for duration of study. Chronic use of NSAIDs is defined as a frequency of \> or = 3 times/wk AND for more than a total of 14 ds a yr.
- The subj has discontinued any other chemopreventive therapy at least 3 mos prior to the Baseline visit and all toxicities have been fully resolved.
- If applicable, the subj has been counseled on smoking cessation.
- If the subject is male, will use adequate contraception during the study.
Exclusion
- The subject has had chemotherapy, immunotherapy, hormonal tx (other than HRT for menopause), or RT within 3 wks of the Baseline visit.
- The subj has not recovered from the acute toxic effects of chemotherapy, immunotherapy, hormonal tx, or RT.
- The subj will need concurrent chemotherapy, radiotherapy, hormonal (other than HRT for menopause), or immunotherapy during the time of study.
- The subj has a history of hypersensitivity to sulindac, COX-2 inhibitors, NSAIDs, salicylates.
- The subj has been diagnosed with or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration.
- The subj has a history of inv cancer within the past 1 yr (excluding non-melanoma skin cancer and in situ cervical cancer).
- The subj has a chronic or acute renal or hepatic disorder or a significant bleeding disorder or any other condition which, in the Institutional Principal Investigator's opinion, might preclude study participation.
- The subj has a past history of or active inflammatory bowel disease (eg. Crohn's disease or ulcerative colitis) or pancreatic disease.
- The subj has received any investigational medication within 30 ds of the Baseline visit or is scheduled to receive an investigational drug during the course of the study.
- The subj is, in the opinion of the Institutional Principal Investigator, not an appropriate candidate for study participation.
- The subj participated in the study previously and was withdrawn.
Key Trial Info
Start Date :
February 23 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2020
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00299195
Start Date
February 23 2006
End Date
January 6 2020
Last Update
November 19 2020
Active Locations (3)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
Amrita Institute of Sciences (AIMS)
Kochi, India
3
Regional Cancer Center (RCC)
Trivandrum, India