The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Sustained M-protein reduction of ≥ 25% from baseline
Day one of each cycle
No
Jeffrey A. Zonder, MD
Principal Investigator
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
CDR0000646899
NCT00942422
November 2009
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |