Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
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.
Interventions
DRUGChinese Herb Huanglian (Coptis chinesis)
Patients will receive capsules of the powdered extract of the huanglian root, which will take by mouth 4 times a day (qid).
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed