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A Phase II Trial of Riluzole in Patients With Advanced Melanoma
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.
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.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Start Date
April 1, 2009
Primary Completion Date
July 1, 2013
Completion Date
July 1, 2013
Last Updated
January 19, 2024
13
ACTUAL participants
riluzole
DRUG
Lead Sponsor
Rutgers, The State University of New Jersey
Collaborators
NCT04079166
NCT04911998
Data Source & Attribution
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