Defined Green Tea Catechin Extract in Preventing Liver Cancer in Patients With Cirrhosis

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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 patients with cirrhosis. II. To determine the effects of Polyphenon E/EGCG treatment on the suppression of gam...

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 patients 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 patients with cirrhosis. II. To study the correlation between gamma-OHPdG levels and mutation frequency and deoxyribonucleic acid (DNA) damage spectrum in the p53 and beta-catenin genes in cirrhotic liver tissue. III. To estimate the fraction of patients 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 and Fibrosis-4 (FIB-4) score. II. To develop a liquid chromatography-mass spectrometry (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. Patients 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. After completion of study intervention, patients are followed up at 28 days.

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