NCT03278925

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

A Phase I Single-arm, Multicenter Pilot Study Aimed at Validating γ-OHPdG as a Biomarker and Testing the Effects of Polyphenon E on Its Levels in Patients With Cirrhosis

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Computed Tomography	Undergo CT
DRUG	Defined Green Tea Catechin Extract	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Pharmacological Study	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Ultrasound	Undergo ultrasound

Timeline

• Start date: 2018-08-09
• Primary completion: 2023-06-16
• Completion: 2024-12-31
• First posted: 2017-09-12
• Last updated: 2024-08-02

Locations

2 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study