Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia

Overview

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.

Full Title of Study: “A Phase II Trial of Polyphenon E for Cervical Cancer Prevention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2010

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:

I. Evaluate the utility of karyometry as an intermediate endpoint biomarker for cervical chemoprevention studies.

OUTLINE:

This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral green tea extract (Polyphenon E®) once daily for 16 weeks in the absence of unacceptable toxicity.

ARM II: Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed for 2 weeks.

Interventions

  • Drug: placebo
    • Given orally
  • Dietary Supplement: defined green tea catechin extract
    • Given orally
  • Other: laboratory biomarker analysis
    • Correlative studies

Arms, Groups and Cohorts

  • Experimental: Arm I
    • Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
  • Placebo Comparator: Arm II
    • Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • No Response – Persistent Oncogenic HPV Positivity, With or Without 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Francisco Garcia, Principal Investigator, Arizona Cancer Center – Tucson

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