Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262743
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2005-12-06
Brief Title:
Green Tea Extract in Treating Patients With Stage 0 Stage I or Stage II Chronic Lymphocytic Leukemia
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase III Study of Daily Oral Polyphenon E in Asymptomatic Rai Stage 0-II Patients With Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Green tea extract contains ingredients that may slow the growth of certain cancers
PURPOSE This phase III 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
PURPOSE This phase III 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MC0419 | OTHER | Mayo Clinic Cancer Center | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| 1155-05 | OTHER | None | None |
| NCI-2009-01227 | REGISTRY | None | None |