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

NCT ID: NCT00014378

Last Updated: 2015-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2007-12-31

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chinese Herb Huanglian (Coptis chinesis)

Group Type: EXPERIMENTAL

Chinese Herb Huanglian (Coptis chinesis)

Intervention Type: DRUG

Patients will receive capsules of the powdered extract of the huanglian root, which will take by mouth 4 times a day (qid).

Interventions

Chinese 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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary K. Schwartz, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-00061

Identifier Type: -

Identifier Source: secondary_id

NCI-H01-0069

Identifier Type: -

Identifier Source: secondary_id

00-061

Identifier Type: -

Identifier Source: org_study_id