Randomized, Double Blind, Placebo-Controlled, Phase IIB Trial of Ketorolac Mouth Rinse Evaluating the Effect of Cyclooxygenase Inhibition on Oropharyngeal Leukoplakia: Collaborative Study of the NCI, NIDCD and the NIDCR

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

Keywords

ClinConnect Summary

In Phase II trials, treatment with ketorolac tromethamine oral rinse has been shown to block periodontal disease progression even in the absence of standard clinical intervention such as scaling and root planing which is routinely done to reduce the periodontal pathogen load that is driving the local destructive host inflammatory response. Resolution of periodontal disease has a favorable effect on normalizing the cellular and biochemical indices of inflammation as reflected by histological changes as well as the levels of prostaglandin E2 (PGE2) and interleukin I beta (IL-1beta). In this t...

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• • Patients must have objective evidence of oral leukoplakia. This includes subjects who have had a previous diagnosis of head and neck or oral cancer, who are currently free of evidence of known cancer for at least three months.
• • Patients must have bidimensionally measurable lesions.
• • Patients must consent to serial photography and biopsy to document response to treatment.
• • All patients old enough to give their own informed consent (greater than or equal to 18 years old) are eligible.
• • Subjects must be excellent performance status (Performance Status 0-1).
• • In addition, they must be otherwise medically fit in the opinion of the PI with no other uncontrolled medical conditions.
• EXCLUSION CRITERIA:
• • Patients with a hypersensitivity to aspirin, lidocaine or non-steroid anti-inflammatory agents or retinoids will be ineligible.
• • Patients using antibiotics, steroids, NSAID, aspirin, probenecid or antihistamines for an extended regimen of at least 10 or more consecutive days, or any immunosuppressants, anticoagulants, dilantin, lithium, methotrexate, phenothiazines, investigational drugs with pharmacological activity that could compromise the test product safety during the 30 days immediately preceding the first treatment visit.
• • Patients with serious or debilitating oral conditions that require extensive dental procedures in order to safely participate in this trial. This trial does not envision the need to do dental procedures (such as root canal or gingival procedure) in order to allow a potential participant to enroll on this study.
• • Individuals with a social or psychiatric situation interfering with study compliance or an unwillingness to undergo the serial oral biopsies will be excluded.
• • Patients with compromised respiratory function manifested by shortness of breath with mild exertion or dependency on supplemental oxygen.
• • Patients with compromised cardiovascular status including poorly controlled angina or congestive heart failure.
• ELIGIBILITY FOR ORAL IMAGING SUBSTUDY:
• • Participation in this substudy requires that patients be enrolled in the parent trial.
• • Subjects must have given their consent and signed supplemental informed consent for the pilot study involving oral imaging.