A Phase 1 interventional study of riluzole and whole-brain radiation therapy in Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Rutgers, The State University of New Jersey. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-02.
Sponsored by Rutgers, The State University of New Jersey · Phase 1, Interventional, and Treatment
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
Secondary
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 9 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Has ≥ 2 brain metastases as demonstrated by baseline MRI
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Drug: riluzole · Radiation: whole-brain 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.
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.
Maximum tolerated dose of riluzole
Time frame: 2.5 years
Long-term toxicity of riluzole
Time frame: .25 years
Neurocognitive function before and after treatment
Time frame: 2.5 years
MRI response of brain metastasis after treatment
Time frame: 2.5 years
Survival
Time frame: 2.5 years
Response of brain metastasis to treatment as a function of the expression of glutamate receptors
Time frame: 2.5 years
This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey