Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014378
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2001-04-10
Brief Title:
Huang Lian Chinese Herb in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study Of The Chinese Herb Huanglian Coptis Chinesis In Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-12
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 The Chinese herb Huang Lian contains ingredients that may slow the growth of cancer cells and may be an effective treatment for solid tumors
PURPOSE Phase I trial to study the effectiveness of Huang Lian in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of Huang Lian in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of Huang Lian Chinese herb in patients with advanced solid tumors
Determine the optimal pharmacologic molecular and biologic parameters of this treatment regimen in these patients
Assess the preliminary therapeutic activity of this treatment regimen in this patient population
OUTLINE This is a dose-escalation study
Patients receive oral Huang Lian Chinese herb 4 times daily Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of Huang Lian until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-liming toxicity
PROJECTED ACCRUAL Approximately 20-30 patients will be accrued for this study
Determine the maximum tolerated dose of Huang Lian Chinese herb in patients with advanced solid tumors
Determine the optimal pharmacologic molecular and biologic parameters of this treatment regimen in these patients
Assess the preliminary therapeutic activity of this treatment regimen in this patient population
OUTLINE This is a dose-escalation study
Patients receive oral Huang Lian Chinese herb 4 times daily Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of Huang Lian until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-liming toxicity
PROJECTED ACCRUAL Approximately 20-30 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-H01-0069 | None | None | None |
| MSKCC-00061 | None | None | None |