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:||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|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Riluzole; Radiation Therapy||
The first dose of Riluzole will be day 0 of study enrollment. WBRT must begin within 48 hours of the initiation of Riluzole therapy. At the completion of radiation, Riluzole should be discontinued and steroids should be tapered over the course of 1-3 weeks, at the discretion of the treating physicians.Radiation: whole-brain radiation therapy
Standard whole brain irradiation will be carried out at 250 cGy per day fractions times 15 to a total dose of 3750 cGy using a standard opposed lateral helmet field with the inferior border inclusive of C1.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018836
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Bruce G. Haffty, MD||Rutgers Cancer Institute of New Jersey|