A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis
- To determine the maximum tolerated dose of riluzole that can be administered
concurrently with standard whole-brain radiotherapy (WBRT) in patients with multiple
- To determine the long-term toxicity of riluzole when administered with WBRT.
- To assess neurocognitive function before and after treatment with riluzole and WBRT.
- To determine the MRI response of brain metastasis after treatment with riluzole and
- To compare survival of patients treated with riluzole and WBRT to published historical
data for patients with brain metastases.
- To evaluate the response of brain metastasis to riluzole and WBRT as a function of the
expression of glutamate receptors on the primary tumor specimen.
OUTLINE: This is a dose-escalation study of riluzole.
Patients receive oral riluzole twice daily beginning on day 0. Beginning within 2 days after
the initiation of riluzole, patients undergo whole-brain radiotherapy for 15 fractions.
Patients undergo neurocognitive and quality-of-life assessments at baseline, at 5 weeks, and
at 3 months.
Tumor tissue samples are collected for laboratory biomarker studies.
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for
2 years, every 6 months for 3 years, and then annually thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of riluzole
Bruce G. Haffty, 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|