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

Memorial Sloan Kettering Cancer Center34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Chinese Herb Huanglian (Coptis chinesis)DRUG

Patients will receive capsules of the powdered extract of the huanglian root, which will take by mouth 4 times a day (qid).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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