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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00262743 |
Purpose
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 |
Dietary Supplement: Polyphenon E |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 Study Completion Date: | March 2011 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: polyphenon E
Designed to assess toxicity, treatment response, and pertinent laboratory measurements in patients with previously untreated, asymptomatic, Rai Stage 0-II CLL.
|
Dietary Supplement: Polyphenon E
Dose Escalation theme. 400 mg p.o. BID to 2000 mg p.o. BID
|
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.
Eligibility| 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:
Contacts and Locations| United States, Arizona | |
| Mayo Clinic in Arizona | |
| Scottsdale, Arizona, United States | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| Study Chair: | Tait D. Shanafelt, MD | Mayo Clinic |
| Principal Investigator: | Jose F Leis, MD | Mayo Clinic |
More Information
| Responsible Party: | Tait D. Shanafelt, M.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00262743 History of Changes |
| Obsolete Identifiers: | NCT00166335 |
| Other Study ID Numbers: | CDR0000454773, P30CA015083, MC0419, 1155-05, NCI-2009-01227 |
| Study First Received: | December 6, 2005 |
| Last Updated: | March 24, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
B-cell chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |