Spots Global Cancer Trial Database for Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

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Trial Identification

Brief Title: Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

Official Title: A Phase I/II Study of Daily Oral Polyphenon E in Asymptomatic, Rai Stage 0-II Patients With Chronic Lymphocytic Leukemia

Study ID: NCT00262743

Conditions

Leukemia

Interventions

Polyphenon E

Study Description

Brief 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 (CLL).

Detailed 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.