Leukemia Clinical Trial
Official title:
A Phase I/II Study of Daily Oral Polyphenon E in Asymptomatic, Rai Stage 0-II Patients With Chronic Lymphocytic Leukemia
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).
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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