huang lian (chinese herb) in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

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.

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 criteria:
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

Keywords: unspecified adult solid tumor, protocol specific