Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003197
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Green Tea Extract in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Evaluation of Green Tea Extract in Adults With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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 as well as prevent the development of new cancers
PURPOSE Phase I trial to study the effectiveness of green tea extract in treating patients with advanced solid tumors that are refractory to standard therapy
PURPOSE Phase I trial to study the effectiveness of green tea extract in treating patients with advanced solid tumors that are refractory to standard therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of green tea extract administered daily to adults with solid tumors II Determine the safety of chronic daily administration of green tea extract in these patients III Investigate the clinical pharmacology of green tea extract in this study IV Document observed antitumor activity of this treatment
OUTLINE This is a dose escalation study of green tea extract Patients receive green tea extract by mouth daily after meals for 4 weeks One patient is entered at each dose level If grade II toxicities are experienced then 2 more patients are entered at the same dose level One patient must complete 4 weeks of therapy and 2 others must complete 2 weeks of therapy with no greater than grade I toxicity before dose escalation proceeds If at least 2 patients experience dose limiting toxicity at any dose level the immediately preceding dose level is considered the maximum tolerated dose MTD At least 6 patients are studied at the MTD Patients may continue therapy for up to 6 months in the absence of toxicity and disease progression Patients are followed every 4 weeks for the duration of treatment and at least one month after completing treatment
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
OUTLINE This is a dose escalation study of green tea extract Patients receive green tea extract by mouth daily after meals for 4 weeks One patient is entered at each dose level If grade II toxicities are experienced then 2 more patients are entered at the same dose level One patient must complete 4 weeks of therapy and 2 others must complete 2 weeks of therapy with no greater than grade I toxicity before dose escalation proceeds If at least 2 patients experience dose limiting toxicity at any dose level the immediately preceding dose level is considered the maximum tolerated dose MTD At least 6 patients are studied at the MTD Patients may continue therapy for up to 6 months in the absence of toxicity and disease progression Patients are followed every 4 weeks for the duration of treatment and at least one month after completing treatment
PROJECTED ACCRUAL Approximately 30 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 |
|---|---|---|---|
| NCI-G98-1375 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066033 | REGISTRY | None | None |