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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)

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