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

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