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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: Chinese Herb Huanglian (Coptis chinesis)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00014378

MSKCC-00061

NCI-H01-0069

00-061

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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