Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Mayo Clinic
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
