NCT00667901

Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2008-04-28
• Last updated: 2009-12-11

Locations

1 site across 1 country: United States