Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
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.
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: whole-brain radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis|
- Maximum tolerated dose of riluzole [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
- Long-term toxicity of riluzole [ Time Frame: .25 years ] [ Designated as safety issue: Yes ]
- Neurocognitive function before and after treatment [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- MRI response of brain metastasis after treatment [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- Response of brain metastasis to treatment as a function of the expression of glutamate receptors [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||Recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675|
|Principal Investigator:||Bruce G. Haffty, MD||Cancer Institute of New Jersey|