Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Dietary Supplement: Huang Lian |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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: | October 2000 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00014378 History of Changes |
| Other Study ID Numbers: | CDR0000068538, MSKCC-00061, NCI-H01-0069 |
| Study First Received: | April 10, 2001 |
| Last Updated: | December 13, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013