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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.
- 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).
- 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.
Primary Purpose: Treatment
defined green tea catechin extract
Mayo Clinic Cancer Center
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-26T22:47:16-0400
RATIONALE: Green tea extract (Polyphenon E) contains ingredients that may prevent the development of cancer. PURPOSE: This phase I trial is studying how well green tea extract works in pr...
RATIONALE: Green tea extract contains ingredients that may slow the growth of certain cancers. It is not yet known whether green tea extract is more effective than a placebo when given bef...
RATIONALE: Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. PURPOSE: This phase I trial is studying how well green tea extract works in treat...
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Polyphenon E, a substance found in green tea, may keep cancer from forming in current or form...
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: Th...
The present study was designed to evaluate the effect of green tea catechin (7500 µg/kg/animal/day) against cadmium-induced testicular dysfunctions and oxidative stress in the testes of mice. For thi...
In recent years, individuals have begun to tend more frequently to some natural and herbal products to be used alone or as a combination with diet and exercise for ensuring the weight loss. Green tea ...
Green tea is rich in polyphenols, including catechins which have antioxidant activities and are considered to have beneficial effects on cardiovascular health. In the present study, we investigated th...
The aim of the study was to compare the antimicrobial activities of freshly-made, heat-treated (HT), and 14 d stored (+)-Catechin solutions with (+)-catechin flavanol isomers in the presence of copper...
Green tea extract (GTE) consumption has been linked to favorable changes in adiposity and bone mineral density (BMD), although it is unknown if these effects are due to green tea catechins or caffeine...
An antioxidant flavonoid, occurring especially in woody plants as both (+)-catechin and (-)-epicatechin (cis) forms.
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.
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 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.
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.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...