Head and Neck Cancer Clinical Trial
Official title:
A Phase IIa Cancer Prevention Trial of the PPAR Gamma Agonist Pioglitazone in Oral Leukoplakia
Verified date | January 2022 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 try to prevent the development or recurrence of cancer. The use of pioglitazone hydrochloride may be effective in preventing head and neck cancer.
Status | Completed |
Enrollment | 21 |
Est. completion date | June 27, 2008 |
Est. primary completion date | June 27, 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Interleukin 6, 8 and Vascular Endothelial Growth Factors Elaboration in the Oral Cavity and Serum | Quantitative studies of serum and saliva components for a pre and post treatment possible biomarker. | Pre (Day 0) and Post (Week 12) Treatment | |
Other | Quantitative Oil Red O, AP2 (FABP4) and FABP5 Staining | Immune histochemistry / tissue staining for a possible biomarker. | Pre (Day 0) and Post (Week 12) Treatment | |
Other | Involucrin and Transglutaminase Staining | Immune histochemistry / tissue staining for a possible biomarker. | Pre (Day 0) and Post (Week 12) Treatment | |
Other | Cyclin D1 and p21 Immune Histochemistry | Immune histochemistry / tissue staining for a possible biomarker. | Pre (Day 0) and Post (Week 12) Treatment | |
Other | Cyclooxygenase-2 Staining | Immune histochemistry / tissue staining for a possible biomarker. | Pre (Day 0) and Post (Week 12) Treatment | |
Other | Piogliotazone Gamma Immune Histochemistry | Immune histochemistry / tissue staining for a possible biomarker. | Pre (Day 0) and Post (Week 12) Treatment | |
Other | Ki 67 Labeling Index | Immune histochemistry / tissue staining for a possible biomarker. | Pre (Day 0) and Post (Week 12) Treatment | |
Other | Apotosis (Cell Death) | Immune histochemistry / tissue staining for a possible biomarker. | Pre (Day 0) and Post (Week 12) Treatment | |
Other | Nf Kappa B p65 | Immune histochemistry / tissue staining for a possible biomarker. | Pre (Day 0) and Post (Week 12) Treatment | |
Primary | Patients' Overall Response | Overall Response= reviewing both the clinical and histological responses and assigning the worst category.
Complete Response (CR) = Clinical CR and Histologic CR, or Histologic CR Partial Response (PR) = Clinical CR or PR and Histologic PR or Stable Disease (SD) Stable Disease (SD) = Clinical SD and Histologic PR or SD Progressive Disease (PD) = Clinical PD and/or Histologic PD |
Week 16 (4 weeks post dose) | |
Secondary | Patients' Clinical Response | Determined by measurement of lesions- Complete Response (CR)= disappearance of all lesions, Partial Response (PR)= >or= 50% decrease in sum of lesions, Stable Disease (SD) = does not meet CR,PR or Progressive Disease (PD), and PD= >or= 25% increase in sum of lesions | Week 16 (4 weeks post dose) | |
Secondary | Patients' Histological (Tissue) Response | Determined by biopsy results before and 4 weeks after treatment: Complete Response (CR) =complete reversal of dysplasia or hyperplasia, Partial Response (PR) = >or=50% decrease in sum of lesions, no increase in 1 or more lesions and no new lesion occurs, Stable Disease (SD0 = not CR, PR or Progressive Disease (PD), PD = >or= 25% increase in sum of lesions or new lesion or progression to invasive carcinoma. | Week 16 (4 weeks post dose) |
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