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The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition

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Trial Information

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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Sustained M-protein reduction of ≥ 25% from baseline

Outcome Time Frame:

Day one of each cycle

Safety Issue:

No

Principal Investigator

Jeffrey A. Zonder, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000646899

NCT ID:

NCT00942422

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous Condition
  • monoclonal gammopathy of undetermined significance
  • smoldering multiple myeloma
  • Neoplasms
  • Monoclonal Gammopathy of Undetermined Significance
  • Paraproteinemias
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Precancerous Conditions

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201