Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT00667901|
Recruitment Status : Terminated (All enrollment, treatment, follow-up & data analysis completed)
First Posted : April 28, 2008
Last Update Posted : December 11, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: riluzole 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||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma|
|Study Start Date :||February 2007|
|Primary Completion Date :||October 2008|
|Study Completion Date :||November 2008|
- Measurement of the inhibition of components of the Grm1 signaling cascade
- Mitoses in nodal metastases and Ki-67 immunostaining (0-3+ scale)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|