Oral Leukoplakia Clinical Trial
Official title:
Phase IIA Trial of Rosiglitazone (Avandia) for Oral Leukoplakia
This phase II trial is studying how well rosiglitazone works in preventing oral cancer in patients with oral leukoplakia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of rosiglitazone may keep cancer from forming in patients with oral leukoplakia
PRIMARY OBJECTIVES:
I. To determine the rate of clinical response of oral premalignant lesions (OPL) to 12 weeks
of therapy with rosiglitazone (Avandia), 8 mg daily, defined as greater than or equal to 50%
reduction in the measured product of perpendicular dimension of the target lesion, or
improvement in the degree of dysplasia.
SECONDARY OBJECTIVES:
I. To determine the rate and degree of change of putative biomarkers of rosiglitazone
efficacy including:
COX-2, cyclin D1, Ki-67, p21/waf1, PPAR gamma, K1 cytokeratin, involucrin, transglutaminase
expressions, and TUNEL.
II. To estimate the correlation between DNA ploidy measurements in OPL with clinical
response and or response of biomarkers to rosiglitazone therapy, and to estimate the
efficacy of rosiglitazone therapy to normalize aberrant DNA ploidy in OPL.
III. To thoroughly assess smoking patterns among trial participants and to examine the
relationship of smoking to treatment response.
IV. To assess the safety of this agent in short-term use in this population.
OUTLINE: This is a multicenter, open-label, nonrandomized study.
Patients receive oral rosiglitazone once daily. Treatment continues for 12 weeks in the
absence of unacceptable toxicity.
After completion of study treatment, patients are followed at 1 week.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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