Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors
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.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: Chinese Herb Huanglian (Coptis chinesis)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Study Of The Chinese Herb Huanglian (Coptis Chinesis) In Patients With Advanced Solid Tumors|
|Study Start Date:||October 2000|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|Experimental: Chinese Herb Huanglian (Coptis chinesis)||
Drug: Chinese Herb Huanglian (Coptis chinesis)
Patients will receive capsules of the powdered extract of the huanglian root, which will take by mouth 4 times a day (qid).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014378
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Gary K. Schwartz, MD||Memorial Sloan Kettering Cancer Center|