Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
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.
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Genetic: western blotting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma|
- Measurement of the inhibition of components of the Grm1 signaling cascade [ Designated as safety issue: No ]
- Mitoses in nodal metastases and Ki-67 immunostaining (0-3+ scale) [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667901
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||James S. Goydos, MD||Rutgers Cancer Institute of New Jersey|