Traditional Chinese Medicine |
Chinese medicine; Oriental Medicine |
Clinical Trial: Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors
This study is no longer recruiting patients.
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 | Treatment or Intervention | Phase |
|---|---|---|
| unspecified adult solid tumor, protocol specific | Drug: Huang Lian Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: herbal medicine / botanical therapy | Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Huang Lian (Chinese Herb) in Patients With Advanced Solid Tumors
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 above, Genders Eligible for Study: Both
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
Location Information
Gary K. Schwartz, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: April 10, 2001
ClinicalTrials.gov Identifier: NCT00014378
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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