A Phase II Trial of Polyphenon E for Cervical Cancer Prevention
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia
Study Overview
Brief Summary
This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea extract may stop cervical cancer from forming in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. It is not yet known whether green tea extract is more effective than a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia.
Detailed Description
PRIMARY OBJECTIVES:
I. Assess the effect of green tea extract (Polyphenon E®) in patients with human papillomavirus (HPV) expression and low-grade cervical intraepithelial neoplasia (CIN 1) in a pre- and post-treatment setting.
SECONDARY OBJECTIVES:
I. Compare the toxicity of green tea extract vs placebo among patients with CIN 1.
TERTIARY OBJECTIVES:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed cervical intraepithelial neoplasia 1 (CIN 1) AND oncogenic human papillomavirus (HPV) positivity
- •At increased risk for developing cervical cancer due to >= 1 of the following criteria (documented 6-12 months ago)*:
- •Positive oncogenic HPV on DNA hybrid capture
- •Low-grade squamous intraepithelial lesion cytology
- •Histopathologically documented CIN 1 on cervical biopsy [Note: *Patients must now have current CIN 1 by histology or colposcopy AND HPV positivity]
- •Cervical dysplasia by colposcopy OR positive biopsy
- •No invasive cervical cancer or high-grade intraepithelial neoplasia on cervical biopsy or endocervical curettage
- •ECOG performance status < 2
- •Total bilirubin < 2 times upper limit of normal (ULN)
- •AST < 2 times ULN
- •ALT normal
- •Creatinine < 2.0 mg/dL
- •Able and willing to return to clinic for study visits once every 4 weeks for the duration of the study
- •No history of allergic reaction to tea or related dietary products
- •No HIV positive patients (or AIDS/HIV-associated complex)
- •No uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Ongoing or active infection other than HPV
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness/social situation that would limit compliance with study requirements
- •No history of any cancer except nonmelanoma skin cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No regular intake of 6 or more servings of tea per week within 1 month prior to study entry
- •No treatment for genital condyloma within 30 days prior to study entry
- •No prior pelvic irradiation
- •No concurrent tea (green, black, or oolong) or tea-derived products
- •No other concurrent investigational agents
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
Intervention: defined green tea catechin extract (Dietary Supplement)
Arm I
Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
Intervention: laboratory biomarker analysis (Other)
Arm II
Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
Intervention: placebo (Drug)
Arm II
Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
Intervention: laboratory biomarker analysis (Other)
Outcomes
Primary Outcomes
No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia
Time Frame: 4 months
Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease
Time Frame: 4 months
Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia
Time Frame: 4 months
Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer
Time Frame: 4 months
Secondary Outcomes
No secondary outcomes reported