A Randomized Study of Sulindac in Oral Premalignant Lesions

• Status: Completed
• Trial end date: 2020-01-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Amrita Institute of Sciences, AIMS, Cochin, India; Narayana Hrudayalaya Hospitals; Regional Cancer Center(RCC), Trivandrum, India; Weill Medical College of Cornell University
• Treatments: Sulindac

Criteria

Inclusion Criteria:

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 Criteria:

• 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.