14378
Last Update Posted: 2015-12-18
Recruiting has ended
All Genders accepted | 18 Years-120 Years |
34 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
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.
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.
Eligibility
Relevant conditions:
Unspecified Adult Solid Tumor, Protocol Specific
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov