Melanoma (Skin) Clinical Trial
Official title:
A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma
RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective
treatment for melanoma.
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.
OBJECTIVES:
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.
;
Masking: Open Label, Primary Purpose: Treatment
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