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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00262743 |
RATIONALE: Green tea extract contains ingredients that may slow the growth of certain cancers.
PURPOSE: This phase I/II trial is studying the side effects and best dose of green tea extract and to see how well it works in treating patients with stage 0, stage I, or stage II chronic lymphocytic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: defined green tea catechin extract |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of Daily Oral Polyphenon E in Asymptomatic, Rai Stage 0-II Patients With Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 73 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Phase I
Phase II
OUTLINE: This is a phase I, dose-escalation study of green tea extract (Polyphenon E) followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of green tea extract (Polyphenon E) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of chronic lymphocytic leukemia (CLL)
Phenotypically characterized B-CLL defined by all of the following criteria:
Patients who require chemotherapy for treatment of CLL, based on any of the following criteria, are excluded:
CLL-related symptoms requiring treatment, including any of the following:
Evidence of progressive marrow failure due to CLL involvement of bone marrow as manifested by the development of worsening anemia (hemoglobin < 11 g/dl) and/or thrombocytopenia (platelet count < 100,000/mm^3)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Tait D. Shanafelt, MD | Mayo Clinic |
Investigator: | Neil E. Kay, MD | Mayo Clinic |
Study ID Numbers: | CDR0000454773, MAYO-MC0419, NCI-7303, CLLT-MAYO-MC0419 |
Study First Received: | December 6, 2005 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00262743 |
Health Authority: | Unspecified |
B-cell chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia |
Chronic lymphocytic leukemia Epigallocatechin gallate Lymphatic Diseases Leukemia Leukemia, Lymphoid |
Immunoproliferative Disorders Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |