A Phase II Trial of Polyphenon E for Cervical Cancer Prevention

Inclusion Criteria

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 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

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 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

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