- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00087386
Tanespimycin in Treating Patients With Stage III-IV Melanoma
Phase II Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC #330507) Diluted in EPL Diluent (NSC #704057) in Metastatic Melanoma Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine if treatment with 17-AAG results in measurable anti-tumor effects and calculate the proportion of clinical responses.
II. Test the hypothesis that treatment with 17-AAG can disrupt the MAPK pathway by depleting intra-tumor stores of RAF kinases and/or downstream proteins such as phospho-ERK, CDK4 and cyclin D1.
III. Determine if either of these effects correlates with the presence of mutated BRAF within the melanoma tumor.
OUTLINE: This is a multicenter study. Patients are stratified according to presence of BRAF mutation in tumor (yes vs no).
Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically or cytologically confirmed melanoma
- Stage III or IV disease
- No primary melanoma of the choroid or mucosa
Measurable disease
- At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
Tumor amenable to biopsy (for the first 10 patients in each stratum only)
- Patients must have measurable disease in addition to the tumor(s) to be biopsied
No brain or epidural metastases
- Completely resected solitary brain metastases allowed provided patient has been free of CNS metastases for >= 6 months
- Performance status - Karnofsky 60-100%
- Performance status - ECOG 0-2
- More than 3 months
- Absolute neutrophil count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- WBC >= 3,000/mm^3
- AST and ALT =< 2.5 times upper limit of normal
- Creatinine normal
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No history of myocardial infarction
- No history of prolonged QTc interval
- No active ischemic heart disease within the past 12 months
- No uncontrolled dysrhythmia or dysrhythmias requiring medication
- No congenital prolonged QT syndrome
- No left bundle branch block
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
- No prior serious allergic reaction to eggs
- No other uncontrolled illness
- No active or ongoing infection requiring systemic antimicrobial treatment
- No psychiatric illness or social situation that would preclude study compliance
No more than 1 prior chemotherapy regimen for metastatic melanoma
- Prior vaccines, cytokines, or interferon alfa is not considered prior therapy unless administered with a chemotherapy drug
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior radiotherapy dose =< 3,000 cGy to fields including substantial marrow
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy field that included the heart (e.g., mantle)
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent medications that may prolong the QTc interval
- No other concurrent anticancer therapy
- No other concurrent investigational agents
No concurrent treatment with any of the following medications or herbal remedies:
Inhibitors of CYP3A4:
- Fluconazole
- Itraconazole
- Ketoconazole
- Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin)
- Midazolam
- Nifedipine
- Verapamil
- Diltiazem
- Terfenadine
- Cyclosporine
- Cisapride
Inducers of CYP3A4:
- Carbamazepine
- Phenobarbital
- Phenytoin
- Rifampin
Herbal extracts and tinctures with CYP3A4 inhibitory activity:
- Hydrastis canadensis (goldenseal)
- Hypericum perforatum (St. John's wort)
- Uncaria tomentosa (cat's claw)
- Echinacea angustifolia roots
- Trifolium pratense (wild cherry)
- Matricaria chamomilla (chamomile)
- Glycyrrhiza glabra (licorice)
- Dillapiol
- Hypericin
- Naringin
- No other concurrent herbal extracts
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (tanespimycin)
Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks.
Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate (complete and partial response)
Time Frame: Up to 3 years
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with stable disease
Time Frame: At 1 year
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At 1 year
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Frequency of toxicities
Time Frame: Up to 3 years
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul Chapman, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-01453
- N01CM62206 (U.S. NIH Grant/Contract)
- 04-056
- NCI-6480
- CDR0000374980
- MSKCC-04056
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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