Overview

This trial is active, not recruiting.

Conditions multiple myeloma and plasma cell neoplasm, precancerous condition
Treatments defined green tea catechin extract, gene expression analysis, protein analysis, laboratory biomarker analysis
Phase phase 2
Sponsor Barbara Ann Karmanos Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date November 2009
End date December 2013
Trial size 8 participants
Trial identifier NCT00942422, CDR0000646899, NCT01589887, P30CA022453, WSU-2009-015

Summary

RATIONALE: Green tea extract contains ingredients that may prevent or slow the growth of monoclonal gammopathy of undetermined significance and/or smoldering multiple myeloma.

PURPOSE: This phase II trial is studying how well green tea extract works in treating patients with monoclonal gammopathy of undetermined significance and/or smoldering multiple myeloma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
defined green tea catechin extract
Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
gene expression analysis
Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the first cycle of therapy.
protein analysis
Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the first cycle of therapy.
laboratory biomarker analysis
Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the first cycle of therapy.

Primary Outcomes

Measure
Sustained M-protein reduction of ≥ 25% from baseline
time frame: Day one of each cycle

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Diagnosis of monoclonal gammopathy of undetermined significance (MGUS) and/or smoldering multiple myeloma (SMM) - Measurable monoclonal protein in the serum (≥ 1.0 g/dL) and/or urine (≥ 500 mg/24 hrs) - No confirmed symptomatic multiple myeloma, defined by any of the following: - Lytic lesions on skeletal survey - Anemia attributable to plasma cell infiltrate in marrow - Hypercalcemia - Renal dysfunction not attributable to other causes PATIENT CHARACTERISTICS: - Life expectancy ≥ 6 months - ANC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9 mg/dL - ALT and AST normal - Total bilirubin normal - Alkaline phosphatase normal - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 30 days after completion of study treatment - Willing to comply with oral home treatment and visit schedule - No concurrent uncontrolled illness including, but not limited to, any of the following: - Active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness or social situation that would compromise compliance with study medication or follow-up visits - No chronic liver disease (e.g., hepatitis B, hepatitis C, or alcoholic cirrhosis) - No high predisposition to gastrointestinal bleeding (e.g., known gastroesophageal varices or active peptic ulcer disease) - No adverse symptoms related to green tea or any of the inactive components present in Polyphenon E capsules PRIOR CONCURRENT THERAPY: - More than 6 months since prior daily ingestion of green tea or green tea extract - At least 4 weeks since prior therapy - No other concurrent investigational or commercial agents or therapies with the intent to treat MGUS and/or SMM

Additional Information

Official title The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study
Principal investigator Jeffrey A. Zonder, MD
Description OBJECTIVES: Primary - Conduct a pilot study investigating the effects of Polyphenon E, a compound extracted from green tea which contains epigallocatechin-3-gallate (EGCG), on monoclonal protein levels in patients with monoclonal gammopathy of undetermined significance and/or smoldering multiple myeloma. Secondary - Collect, process, and store blood and marrow specimens for future measurement of the biologic effects of Polyphenon E on the plasma cells of these patients by utilizing proteosome activity assays and gene expression profiling. OUTLINE: Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo blood, urine, and bone marrow sample collection periodically for correlative laboratory studies. Samples are analyzed for monoclonal protein (M-protein) levels, proteosome function, and gene expression.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute.