Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Drug: Chinese Herb Huanglian (Coptis chinesis)
- Registration Number
- NCT00014378
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chinese Herb Huanglian (Coptis chinesis) Chinese Herb Huanglian (Coptis chinesis) -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States