Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Summary
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.
Description
OBJECTIVES:
Phase I
- Determine the maximally tolerated dose of green tea extract (Polyphenon E) in patients with previously untreated stage 0-II chronic lymphocytic leukemia.
- Describe the dose-limiting toxicity of green tea extract (Polyphenon E).
Phase II
- Evaluate the response rate and response duration of patients with previously untreated, asymptomatic Rai stage 0-II chronic lymphocytic leukemia treated with green tea extract (Polyphenon E) for 6 months at the MTD.
- Further characterize toxicity.
OUTLINE: This is a phase I, dose-escalation study of green tea extract (Polyphenon E) followed by a phase II study.
- Phase I: Patients receive oral green tea extract (Polyphenon E) once or twice daily for 4 weeks. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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.
- Phase II: Patients receive green tea extract (Polyphenon E) as in the phase I portion of the study at the MTD.
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.
Study Design
Primary Purpose: Treatment
Conditions
Leukemia
Intervention
defined green tea catechin extract
Location
Mayo Clinic Cancer Center
Rochester
Minnesota
United States
55905
Status
Active, not recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00262743
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Catechin
An antioxidant flavonoid, occurring especially in woody plants as both (+)-catechin and (-)-epicatechin (cis) forms.
Leukemia Virus, Murine
Species of GAMMARETROVIRUS, containing many well-defined strains, producing leukemia in mice. Disease is commonly induced by injecting filtrates of propagable tumors into newborn mice.
Thyroid Extract, Desiccated
A dehydrated extract of thyroid glands. After the removal of fat and connective tissue, the extract is dried or lyophilized to yield a yellowish to buff-colored amorphous powder containing 0.17-0.23% of iodine.
Algae, Green
Algae of the division Chlorophyta, in which the green pigment of CHLOROPHYLL is not masked by other pigments. Green algae have over 7000 species and live in a variety of primarily aquatic habitats. Only about ten percent are marine species, most live in freshwater. They are more closely related to the green vascular land PLANTS than any other group of algae.
Abelson Murine Leukemia Virus
A replication-defective strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) capable of transforming lymphoid cells and producing a rapidly progressing lymphoid leukemia after superinfection with FRIEND MURINE LEUKEMIA VIRUS; MOLONEY MURINE LEUKEMIA VIRUS; or RAUSCHER VIRUS.
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Effect of different doses of un-fractionated green & black tea extracts on thyroid physiology.
Tea is a rich source of polyphenolic flavonoids including catechins, which are thought to contribute to the health benefits of it. Flavonoids have been reported to have antithyroid and goitrogenic eff...
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