Defined Green Tea Catechin Extract in Treating Patients With Plasma Cell Neoplasm Or Smoldering Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01589887
First received: October 27, 2011
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

This pilot phase II trial studies how well defined green tea catechin extract works in treating patients with plasma cell neoplasm or smoldering multiple myeloma. Green tea extract contains ingredients that may prevent or slow the growth of certain cancers


Condition Intervention Phase
Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Dietary Supplement: defined green tea catechin extract
Biological: 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: 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 at least 25% [ Time Frame: Baseline, day 8 of course 1, and day 1 of each subsequent course ] [ Designated as safety issue: No ]
    Defined as two successive measurements at least 28 days apart. Success will be estimated as binary proportion and 95% confidence intervals calculated using Wilson's method.


Estimated Enrollment: 17
Study Start Date: November 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (Polyphenon E)
Patients receive defined green tea catechin extract orally PO QD 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
Given PO
Other Name: Polyphenon E
Biological: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVE:

I. Conduct a pilot study investigating the effects of Polyphenon E (defined green tea catechin extract), a compound extracted from green tea, on monoclonal protein (M-protein) levels in patients with monoclonal gammopathy of undetermined significance (MGUS) and/or smoldering multiple myeloma (SMM).

SECONDARY OBJECTIVES:

I. Collect, process and store blood and marrow specimens for future measurement of the biologic effects of Polyphenon E on the plasma cells of patients with MGUS and/or SMM utilizing proteosome activity assays and gene expression profiling.

OUTLINE:

Patients receive defined green tea catechin extract orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Measurable monoclonal protein in the serum (for immunoglobin [Ig]G or IgM, >= 1.0 g/dL using serum protein electrophoresis [SPEP]/immunofixation electrophoresis [IFE]; for IgA, an SPEP/IFE confirming the presence of a monoclonal IgA band plus a quantitative IgA level of >= 750 mg/dL) OR measurable urine Bence Jones paraprotein (>= 500mg/24hrs) OR a measurable serum free light chain (FLC), defined as an involved FLC level of >10 mg/dl, and a serum FLC ratio that is abnormal
  • Neutrophil count >= 1,500
  • Platelet count >= 100,000
  • Hemoglobin >= 9mg/dL
  • Alanine aminotransferase (ALT) =< institutional upper limit of normal (IULN)
  • Aspartate aminotransferase (AST) =< IULN
  • Total bilirubin =< IULN
  • Alkaline phosphatase =< IULN
  • Any ethnic group
  • Prior therapy is allowed if >= 4 weeks prior to registration
  • Life expectancy of at least 6 months
  • Ability to understand and the willingness to sign a written informed consent document
  • Willingness to comply with oral home treatment and visit schedule
  • Patients with reproductive capacity must be willing to use adequate contraception (barrier contraception, birth control pills, or other highly effective hormonal agents) or abstain from sexual activity for the duration of the study and 30 days beyond the end of therapy

Exclusion Criteria:

  • Pregnant women
  • Breastfeeding women
  • Confirmed symptomatic multiple myeloma (MM), 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
  • Uncontrolled intercurrent illness, including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situations that would compromise compliance with study medication or follow up visits
  • Patients with high predisposition to gastrointestinal bleeding, such as known gastroesophageal varices or active peptic ulcer disease
  • Patients with chronic liver disease (such as hepatitis B, hepatitis C, or alcoholic cirrhosis)
  • Prior daily ingestion of green tea or green tea extract within 6 months of study entry
  • Patients who have previously experienced any adverse symptoms related to green tea or any of the inactive components present in Polyphenon E capsules
  • Concurrent use of investigational or commercial agent or therapy with the intent to treat MGUS and/or SMM
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589887

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 Zonder Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Zonder, Jeffrey, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01589887     History of Changes
Other Study ID Numbers: 2009-015, NCI-2010-02327
Study First Received: October 27, 2011
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Multiple Myeloma
Neoplasms, Plasma Cell
Hypergammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
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 April 17, 2014