A Phase II Trial of Riluzole in Patients With Advanced Melanoma
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.
Interventional
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
No
James S. Goydos, MD
Principal Investigator
Cancer Institute of New Jersey
United States: Food and Drug Administration
CDR0000637646
NCT00866840
April 2009
December 2014
Name | Location |
---|---|
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |