This phase I trial studies the side effects and best dose of defined green tea catechin extract and to see how well it works in preventing liver cancer in participants with cirrhosis. Higher levels of the molecule gamma-OHPdG may be found in participants with cirrhosis, which may mean a higher risk of the development of liver cancer. Defined green tea catechin extract may work better to lower levels of gamma-OHPdG and prevent the development of liver cancer.
PRIMARY OBJECTIVES: I. To establish maximum tolerated dose (MTD) and to collect safety data of defined green tea catechin extract (Polyphenon E/epigallocatechin gallate \[EGCG\]) treatment in participants with cirrhosis. II. To determine the effects of Polyphenon E/EGCG treatment on the suppression of gamma-hydroxy-1,N(2)-propanodeoxyguanosine (gamma-OHPdG) levels in cirrhotic liver. SECONDARY OBJECTIVES: I. To collect Polyphenon E/EGCG pharmacokinetic data in participants with cirrhosis. II. To determine the effects of Polyphenon E/EGCG treatment on the suppression of gamma-hydroxy-1,N(2)-propanodeoxyguanosine (gamma-OHPdG) levels in cirrhotic liver by liquid chromatography-mass spectrometry (LC-MS) assay from baseline to post-treatment. III. To estimate the fraction of participants with liver cirrhosis that have high levels of gamma-OHPdG. EXPLORATORY OBJECTIVES: I. To assess the effects of Polyphenon E/EGCG on the grade of cirrhosis as measured by FibroScan (registered trademark) and Fibrosis-4 (FIB-4) score. II. To develop a LC-MS and/or enzyme-linked immunosorbent assay (ELISA)-based method for detecting urinary and blood gamma-OHPdG, to correlate with liver gamma-OHPdG levels. III. To evaluate any hepatocellular carcinoma (HCC) development during the treatment. OUTLINE: This is a dose-escalation study. Participants receive defined green tea catechin extract orally (PO) once daily (QD) or twice daily (BID) for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) at screening and on study, undergo collection of blood samples on study, and may undergo biopsy at screening and on study. After completion of study intervention, participants are followed up at 28 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
14
Undergo biopsy
Undergo collection of blood samples
Undergo CT
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Puerto Rico
San Juan, Puerto Rico
Maximum tolerated dose of Polyphenon E
Will be defined as the dose at which =\< 1 subjects out of 6 experiences a grade 3 or higher toxicity based on Common Terminology Criteria for Adverse Events criteria.
Time frame: Up to 4 weeks
Change in gamma-hydroxy-1,N(2)-propanodeoxyguanosine (gamma-OHPdG) expression in cirrhotic liver
Will be assessed by immunohistochemistry. Will use a nonparametric Wilcoxon test to compare the post-pre differences to zero.
Time frame: Baseline up to 24 weeks
Fraction of patients with liver cirrhosis that have high levels of gamma-OHPdG
Will use descriptive statistics.
Time frame: Up to 24 weeks
Change in gamma-OHPdG
Descriptive statistics (mean, range) will be used to summarize this continuous outcome by dose level. A nonparametric trend test will be used to examine whether there is a trend for greater reduction in gamma-OHPdG as the dose level increases.
Time frame: Baseline up to 24 weeks
Polyphenon E pharmacokinetic data in blood and urine in patients with cirrhosis
Clearance of Polyphenon E will be compared among cirrhotic liver patients in this study and results from this population will be compared with non-cirrhotic historical control participants.
Time frame: Prior to and at 1.5, 3.5, and 8.5 hours after the first dose of Polyphenon E on day 1
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Given PO
Correlative studies
Undergo MRI
Correlative studies
Ancillary studies
Undergo ultrasound