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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00014378
Collaborator
National Cancer Institute (NCI) (NIH)
34
Enrollment
1
Location
1
Arm
86
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chinese Herb Huanglian (Coptis chinesis)
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study Of The Chinese Herb Huanglian (Coptis Chinesis) In Patients With Advanced Solid Tumors
Study Start Date :
Oct 1, 2000
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chinese Herb Huanglian (Coptis chinesis)

Drug: 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).

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan-Kettering Cancer Center New York New York United States 10021

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00014378
    Other Study ID Numbers:
    • 00-061
    • MSKCC-00061
    • NCI-H01-0069
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Dec 18, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Memorial Sloan Kettering Cancer Center
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Dec 18, 2015