Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Zonder, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00942422
First received: July 17, 2009
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Precancerous Condition
Dietary Supplement: defined green tea catechin extract
Genetic: gene expression analysis
Genetic: protein analysis
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Sustained M-protein reduction of ≥ 25% from baseline [ Time Frame: Day one of each cycle ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: November 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: defined green tea catechin extract / correlative analysis
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.
Dietary Supplement: 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.
Genetic: 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.
Genetic: 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.
Other: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942422

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Jeffrey A. Zonder, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey Zonder, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00942422     History of Changes
Obsolete Identifiers: NCT01589887
Other Study ID Numbers: CDR0000646899, P30CA022453, WSU-2009-015
Study First Received: July 17, 2009
Last Updated: September 20, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
monoclonal gammopathy of undetermined significance
smoldering multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Precancerous Conditions
Hypergammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014