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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00099021
Other study ID # NCI-2009-00862
Secondary ID NCI-2009-00862CD
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2003
Est. completion date June 27, 2008

Study information

Verified date January 2022
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 try to prevent the development or recurrence of cancer. The use of pioglitazone hydrochloride may be effective in preventing head and neck cancer.


Description:

PRIMARY OBJECTIVES: I. Determine whether pioglitazone (pioglitazone hydrochloride) reverses leukoplakia in patients with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia. SECONDARY OBJECTIVES: I. Determine the safety and tolerability of this drug in these patients. OUTLINE: This is an open-label study. Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) for 12 weeks in the absence of disease progression, unacceptable toxicity, or the development of carcinoma. Patients are followed up at 4, 8, 12, and 16 weeks.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
pioglitazone hydrochloride
Given PO

Locations

Country Name City State
United States University of Minnesota Medical Center-Fairview Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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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