Status:
COMPLETED
Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Oral Leukoplakia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well pioglitazone hydrochloride works in preventing head and neck cancer in patients who have oral leukoplakia. Chemoprevention therapy is the use of certain drugs to t...
Detailed Description
PRIMARY OBJECTIVES: I. Determine whether pioglitazone (pioglitazone hydrochloride) reverses leukoplakia in patients with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia. SECONDAR...
Eligibility Criteria
Inclusion
- Criteria:
- ECOG 0-2
- Diagnosis of oral cavity or oropharyngeal leukoplakia meeting 1 of the following criteria:
- Biopsy-proven hyperplasia in high-risk anatomic areas (e.g., floor of the mouth, mobile tongue, oropharynx, or in any erythroplakia lesion)
- Mild, moderate, or severe dysplasia at any site of the oral cavity or oropharynx within the lesion
- Measurable lesion that is clinically characterized by leukoplakia, erythroplakia, or erythroleukoplakia
- Able to be assessed by bi-directional measurements
- Life expectancy: More than 3 months
- Hemoglobin \>= lower limit of normal for males and post-menopausal females OR
- Hemoglobin \>= 11 g/dL for premenopausal females
- WBC \> 3,000/mm\^3
- Hepatic: Bilirubin \< 1.5 times upper limit of normal (ULN); AST and ALT \< 1.5 times ULN
- Renal: BUN \< 1.5 times ULN; Creatinine \< 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No contraindication to thiazolidinediones
- No allergy to pioglitazone or other thiazolidinediones
- No serious oral infection
- No invasive carcinoma within the past 60 months except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No concurrent malignancy
- More than 3 months since prior biologic or immunologic therapy
- No concurrent insulin for diabetes
- No prior radiotherapy to the oral cavity
- More than 3 months since prior chemopreventative agents
- More than 3 months since prior experimental therapy
- More than 3 months since prior megadose vitamins or alternative therapy
- No prior thiazolidinediones
- No prior participation in this study
- No concurrent pharmacologic treatment for diabetes
- Concurrent chronic use of non-steroidal anti-inflammatory drugs allowed
- Platelet count \> 125,000/mm\^3
- Index lesion must be located in an anatomic site accessible by punch biopsy
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00099021
Start Date
June 1 2003
End Date
June 27 2008
Last Update
February 11 2022
Active Locations (1)
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1
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455