Clinical Trial Details
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NCT01018836 : Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
PhasePhase 1
AgesMin: 18 Years Max: N/A

- Histologically confirmed solid tumor

- Has ? 2 brain metastases as demonstrated by baseline MRI

- Patients with only 1 metastasis are eligible provided the metastasis is too
large for radiosurgery and not amenable to surgical resection

- Not being considered for surgical resection

- Eligible to undergo whole-brain radiotherapy (WBRT)


- ECOG performance status 0-2

- ANC ? 1,000/?L

- Platelet count ? 50,000/?L

- Total bilirubin ? 1.5 times upper limit of normal (ULN)

- AST/ALT ? 1.5 times ULN

- INR ? 1.5 times ULN

- Sodium normal

- Thyroid-stimulating hormone normal

- Negative pregnancy test

- Fertile patients must use effective contraception before, during, and for ? 6 months
after completion of study treatment

- No headaches, disequilibrium, vertigo, or dizziness

- No known history of hepatitis B or C

- No concurrent serious systemic disorder (including active infection) that would
compromise the safety of the patient or compromise the patient's ability to complete
the study, at the discretion of the investigator

- No history of allergic reactions attributed to riluzole


- No prior WBRT

- At least 2 weeks since prior systemic chemotherapy

- No systemic chemotherapy during and for ? 3 weeks after completion of WBRT

- Radiosurgical boosts to ? 3 metastases allowed, based on the discretion of the
treating radiation oncologist
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