Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
NCT ID: NCT00667901
Last Updated: 2009-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
15 participants
INTERVENTIONAL
2007-02-28
2008-11-30
Brief Summary
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PURPOSE: This early phase I trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that can be removed by surgery.
Detailed Description
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Primary
* To evaluate the potential effects of glutamate receptor blockade on cellular pathways important in the genesis and progression of melanoma in patients with stage III or IV melanoma undergoing surgical resection.
* To determine whether treatment with riluzole alters expression of activated PLC and ERK in lysates from tumor tissue biopsies.
Secondary
* Determine if treatment with riluzole affects the overall metabolic activity of melanoma tumors as measured by pre- and post-treatment PET scanning, pre- and post-treatment tumor mitotic rate evaluation, and pre- and post-treatment immunohistochemical staining for Ki-67.
OUTLINE: Patients receive oral riluzole twice daily for 14 days. Within 24 hours after the final dose of riluzole, patients undergo standard surgical resection.
Patients undergo tumor tissue sample collection at baseline and during surgery for laboratory studies. Samples are analyzed by routine histology, immunohistochemistry, western blotting, and RT-PCR for Grm1 expression, - RAS and B-raf mutations, PLC and MAP kinase activity, Ki-67 staining, and mitotic rate. Patients also undergo blood sample collection periodically for pharmacokinetics studies.
PET scans are obtained before and after treatment to evaluate the overall metabolic activity of the tumor and how this activity changes with inhibition of the Grm1 pathway.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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riluzole
protein expression analysis
reverse transcriptase-polymerase chain reaction
western blotting
immunohistochemistry staining method
laboratory biomarker analysis
pharmacological study
neoadjuvant therapy
therapeutic conventional surgery
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0 or 1
* ANC ≥ 1,000/mm³
* Platelet count ≥ 50,000/mm³
* AST/ALT ≤ 3 times upper limit of normal (ULN)
* Total bilirubin normal
* Calculated creatinine clearance ≥ 50 mL/min
* INR ≤ 25% of ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 48 hours after completion of study treatment
* No history of allergic reaction to riluzole or similar compounds
* No known history of hepatitis B or C
PRIOR CONCURRENT THERAPY:
* Not specified
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Medicine and Dentistry of New Jersey
OTHER
Responsible Party
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UMDNJ/CINJ
Principal Investigators
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James S. Goydos, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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CINJ-090603
Identifier Type: -
Identifier Source: secondary_id
CINJ-IRB-0220060225
Identifier Type: -
Identifier Source: secondary_id
CDR0000592958
Identifier Type: -
Identifier Source: org_study_id