Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00014378


Primary Contact:

Study Chair
Gary K. Schwartz, MD
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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