Status:
COMPLETED
Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Cervical Intraepithelial Neoplasia Grade 1
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 i...
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-...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00303823
Start Date
September 1 2005
End Date
February 1 2011
Last Update
May 5 2015
Active Locations (1)
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1
Arizona Cancer Center - Tucson
Tucson, Arizona, United States, 85724-5024