Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs, such as
riluzole, may make tumor cells more sensitive to radiation therapy. Giving riluzole together
with whole-brain radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of riluzole when
given together with whole-brain radiation therapy in treating patients with brain
metastases.
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of riluzole that can be administered
concurrently with standard whole-brain radiotherapy (WBRT) in patients with multiple
brain metastases.
Secondary
- 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
WBRT.
- 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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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