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

NCT00014378 | Completed Phase 1

• 3 other identifiers: 00-061MSKCC-00061NCI-H01-0069
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

Chinese Herb Huanglian (Coptis chinesis)

EXPERIMENTAL

Drug: Chinese Herb Huanglian (Coptis chinesis)

Interventions

Chinese Herb Huanglian (Coptis chinesis) DRUG

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

Chinese Herb Huanglian (Coptis chinesis)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Coptidis rhizoma extract

Study Officials

• Gary K. Schwartz, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: January 27, 2003
• Study Start: October 1, 2000
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

US (1)