Clinical trial NCT00014378: Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors
Official title: A Phase I Study Of The Chinese Herb Huanglian (Coptis Chinesis) In Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gary K. Schwartz, MD
role: STUDY_CHAIR
References: