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:
Barbara Ann Karmanos Cancer Institute
Collaborator:
Information provided by:
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00942422
First received: July 17, 2009
Last updated: August 8, 2012
Last verified: August 2012
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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 |
| Primary Completion Date: | March 2012 (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
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 A. Zonder, Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00942422 History of Changes |
| Other Study ID Numbers: | CDR0000646899, P30CA022453, WSU-2009-015 |
| Study First Received: | July 17, 2009 |
| Last Updated: | August 8, 2012 |
| 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 May 16, 2013