A Phase II Trial of Riluzole in Patients With Advanced Melanoma
- Determine whether administration of a daily dose of riluzole results in tumor
shrinkage, as measured by RECIST criteria, in patients with advanced melanoma.
- 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor shrinkage, as measured by RECIST criteria
Treatment start date to date of best response
James S. Goydos, MD
Cancer Institute of New Jersey
United States: Food and Drug Administration
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|