|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00942422 |
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 II |
| 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 |
| Estimated Enrollment: | 17 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 |
DISEASE CHARACTERISTICS:
Diagnosis of monoclonal gammopathy of undetermined significance (MGUS) and/or smoldering multiple myeloma (SMM)
No confirmed symptomatic multiple myeloma, defined by any of the following:
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Barbara Ann Karmanos Cancer Institute 800-527-6266 | |
| Principal Investigator: | Jeffrey A. Zonder, MD | Barbara Ann Karmanos Cancer Institute |
More Information
| 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: | November 1, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
monoclonal gammopathy of undetermined significance smoldering multiple myeloma |
|
Neoplasms Disease Monoclonal Gammopathy of Undetermined Significance Paraproteinemias Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Precancerous Conditions Pathologic Processes 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 |