Spots Global Cancer Trial Database for Pioglitazone for Oral Premalignant Lesions
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Trial Identification
Brief Title: Pioglitazone for Oral Premalignant Lesions
Official Title: Phase IIB Randomized, Placebo Controlled Trial of Pioglitazone for Oral Premalignant Lesions an Inter-consortium Collaborative Study
Study ID: NCT00951379
Conditions
Study Description
Brief Summary: The goal of this clinical research study is to learn how Actos (pioglitazone) may affect oral premalignant lesions (OPLs) and/or the risk of mouth cancer. The safety of this drug will also be studied.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the clinical and histologic response of oral premalignant lesions to 24 weeks of therapy with pioglitazone, 45 mg once daily (qd), defined as 50% or greater reduction in the sum of all measured products of perpendicular dimensions of target lesions, or improvement in the degree of dysplasia or hyperplasia. SECONDARY OBJECTIVES: I. To determine the degree of change of putative biomarkers of pioglitazone efficacy including (but not restricted to) and in order of priority, tissue levels of: * PPAR gamma, * cyclin D1 and p21 as indirect measures of pharmacological effect * TUNEL for apoptosis and Ki-67 for proliferation * transglutaminase and involucrin as markers of squamous differentiation * 15-PGDH, loss of heterozygosity (LOH). II. To determine the degree of change of C-reactive protein (CRP) in plasma. III. To assess tobacco and alcohol use among trial participants and to examine the relationship of tobacco and alcohol use to treatment response. IV. To assess the safety of this agent in this population. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) for 24 weeks. ARM II: Patients receive placebo PO QD for 24 weeks. After completion of study treatment, patients are followed up for 2 weeks.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Weill Medical College of Cornell University, New York, New York, United States
Medical University of South Carolina, Charleston, South Carolina, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
BC Cancer Agency (Vancouver Cancer Centre), Vancouver, British Columbia, Canada
European Institute of Oncology, Milano, , Italy
Contact Details
Name: Powel H. Brown
Affiliation: University of Texas MD Anderson Cancer Center, Consortium PI
Role: PRINCIPAL_INVESTIGATOR
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