NCT00611650TerminatedPhase 2
Phase II Trial of Polyphenon E in Current and Former Smokers With Bronchial Dysplasia
British Columbia Cancer Agency1 site in 1 country23 target enrollmentStarted: October 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Change in the severity of dysplasia (as defined by WHO criteria) in bronchial biopsy specimens as assessed at baseline and at 3 months
Study Overview
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Polyphenon E, a substance found in green tea, may keep cancer from forming in current or former smokers with bronchial dysplasia.
PURPOSE: This randomized phase II trial is studying the side effects and how well green tea extract works in treating current or former smokers with bronchial dysplasia.
Detailed Description
OBJECTIVES:
Primary
- To evaluate the efficacy and safety of Polyphenon E, a defined green tea catechin extract, in current or former smokers with bronchial dysplasia and increased inflammatory load as measured by C-reactive protein.
Secondary
- To evaluate the ability of Polyphenon E to modulate other surrogate endpoint biomarkers of oxidation stress, inflammation, aberrant methylation, cell cycle regulation, apoptosis, oncogene/tumor suppressor gene expression, as well as phase I and II enzyme regulation in biological samples from these patients.
- To establish a library of optical coherent tomography (OCT) images of the bronchial epithelium with corresponding histopathology, nuclear morphometry, and other biomarker information.
- To assess the potential of OCT as a non-biopsy method for evaluating chemoprevention agents.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Experimental
Patients receive oral Polyphenon E twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
Intervention: defined green tea catechin extract (Drug)
Arm II
Placebo Comparator
Patients receive a placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
Intervention: placebo (Other)
Outcomes
Primary Outcomes
Change in the severity of dysplasia (as defined by WHO criteria) in bronchial biopsy specimens as assessed at baseline and at 3 months
Time Frame: 3 months
Secondary Outcomes
- Change in the morphometric index in bronchial biopsy specimens as assessed at baseline and at 3 months(3 months)
- Change in the concentrations (or grades) of Ki-67, p53, cleaved caspase-3, and VEGF in bronchial biopsy specimens as assessed by immunostaining at baseline and at 3 months(3 months)
- Methylation biomarkers in bronchoalveolar lavage (BAL) cells as assessed at baseline and at 3 months(3 months)
- Oncogene/ tumor suppressor gene expression in bronchial brush cells as assessed by cDNA microarray analysis at baseline and at 3 months(3 months)
- Phase I and II enzyme regulation in bronchial brush cells as assessed by Affymetrix microarray analysis at baseline and at 3 months(3 months)
- Change in C-reactive protein levels in plasma as assessed by enzyme-linked immunoassay (ELISA) at baseline and then monthly for 3 months(3 months)
- Volumetric measurement of CT-detected lung nodules at baseline and then every 3-12 months for up to 24 months, depending on the size of the nodule(24 months)
- Change in the concentrations (or grades) of surfactant protein D, oxidized glutathione, interleukin (IL)-6, IL-13, and MPIF-1 in plasma and BAL cells as assessed by ELISA at baseline and at 3 months(3 months)
Investigators
Study Sites (1)
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