NCT00866840

Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

A Phase II Trial of Riluzole in Patients With Advanced Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 120 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 phase II trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

Detailed description

OBJECTIVES: Primary * Determine whether administration of a daily dose of riluzole results in tumor shrinkage, as measured by RECIST criteria, in patients with advanced melanoma. Secondary * Determine the long-term toxicity of riluzole when administered to these patients. * Compare the survival of these patients with historical controls. OUTLINE: Patients receive oral riluzole twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	riluzole	100 mg orally twice daily

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2009-03-23
• Last updated: 2024-01-19
• Results posted: 2022-09-28

Locations

1 site across 1 country: United States