Viewing Study NCT00369174



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Study NCT ID: NCT00369174
Status: COMPLETED
Last Update Posted: 2013-02-13
First Post: 2006-08-24

Brief Title: Rosiglitazone Maleate in Treating Patients With Oral Leukoplakia
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: Phase IIA Trial of Rosiglitazone Avandia for Oral Leukoplakia
Status: COMPLETED
Status Verified Date: 2013-01
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: 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
Detailed Description: 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 p21waf1 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

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
Secondary IDs
Secondary ID Type Domain Link
P30CA016672 NIH None httpsreporternihgovquickSearchP30CA016672
2005-0485 None None None
N01CN35159 NIH None None
P30CA008748 NIH None None