Spots Global Cancer Trial Database for Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

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Trial Identification

Brief Title: Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Official Title: A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis

Study ID: NCT01018836

Conditions

Metastatic Cancer

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

riluzole

whole-brain radiation therapy

Study Description

Brief Summary: 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.

Detailed Description: 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.