Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Study Of The Chinese Herb Huanglian (Coptis Chinesis) In Patients With Advanced Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: Chinese Herb Huanglian (Coptis chinesis)


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor refractory to standard therapy or for which no standard therapy exists Measurable or evaluable disease No CNS primary tumor or metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,500/mm^3 Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST and ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No history of cardiac arrhythmias (including atrial fibrillation) No congestive heart failure No angina or myocardial infarction within the past 6 months QTc interval no greater than 0.48 sec Other: Potassium at least 3.5 mEq/L Magnesium at least 1.4 mEq/L No mental incapacity that would preclude informed consent No serious or uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: At least 2 weeks since prior herbal therapy for cancer and recovered No concurrent class IA or III antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide, sotalol, amiodarone, ibutilide, almokalant, or dofetilide) No concurrent tricyclic antidepressants (e.g., amitriptyline, doxepin, desipramine, imipramine, or clomipramine) No concurrent antiseizure medication (including dilantin and phenobarbital) for any underlying seizure disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese Herb Huanglian (Coptis chinesis)<br> | Drug: Chinese Herb Huanglian (Coptis chinesis)<br>* Patients will receive capsules of the powdered extract of the huanglian root, which will take by mouth 4 times a day (qid).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific