Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00014378
Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing Chinese Herb Huanglian (Coptis chinesis) in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Chinese Herb Huanglian (Coptis chinesis)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Dec 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase I Study Of The Chinese Herb Huanglian (Coptis Chinesis) In Patients With Advanced Solid Tumors
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.
Read the 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.
- Being tested
- Chinese Herb Huanglian (Coptis chinesis)
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Chinese Herb Huanglian (Coptis chinesis) | Experimental | Not described Receives: Drug: Chinese Herb Huanglian (Coptis chinesis) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2000
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gary K. Schwartz, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014378
- Sponsor's protocol ID
- 00-061
- Other IDs
- MSKCC-00061, NCI-H01-0069
- Status last verified
- Dec 2015
- First submitted
- 10 Apr 2001
- Last updated
- 18 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of The Chinese Herb Huanglian (Coptis Chinesis) In Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00014378
- Acronym / sponsor ID
- 00-061
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2000
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese Herb Huanglian (Coptis chinesis) | Experimental | Drug: Chinese Herb Huanglian (Coptis chinesis) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Chinese Herb Huanglian (Coptis chinesis) |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary K. Schwartz, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chinese Herb Huanglian (Coptis chinesis) in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.