• Effect of green tea extract (Polyphenon E) on human papillomavirus (HPV) expression by Digene hybrid capture oncogenic HPV expression before study and 4 months following study completion [ Designated as safety issue: No ]
  
• Effect of this drug on low grade cervical dysplasia by clinical pathology before study and 4 months following study completion [ Designated as safety issue: No ]
  

• Toxicity of this drug versus placebo as measured by CTCAE version 3 for 4 months during study [ Designated as safety issue: Yes ]
  
• Utility of karyometry as an intermediate endpoint biomarker by karyometry average nuclear abnormality before study and 4 months following study completion [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• 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

• Compare the toxicity of green tea extract vs placebo among patients with CIN 1.

Tertiary

• 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 or 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.

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• 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 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

PATIENT CHARACTERISTICS:

• 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 colposcopic exams 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

PRIOR CONCURRENT THERAPY:

• 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