Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia
Condition: Cervical Cancer; Cervical Intraepithelial Neoplasia Grade 1; Human Papilloma Virus Infection
MeSH terms: Papillomavirus Infections; Uterine Cervical Neoplasms; Neoplasms; Carcinoma in Situ; Papilloma; Uterine Cervical Dysplasia
Intervention: placebo; defined green tea catechin extract; laboratory biomarker analysis
Intervention description: Given orally; Given orally; Correlative studies
Intervention MeSH terms: Epigallocatechin gallate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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