Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593)

Inclusion Criteria

• •Patients with newly diagnosed brain metastases deemed to be eligible for radiosurgery.
• •Subject must have cytologically or histologically confirmed malignancy (this is the original malignancy, not the brain metastases).
• •A diagnostic contrast-enhanced MRI of the brain must be performed within 60 days prior to registration. The contrast-enhancing intraparenchymal brain tumor must be well visualized.
• •History and physical with neurological examination, height, and weight within 14 days prior to registration
• •No dexamethasone use (or any other corticosteroid use with the purpose of treating cerebral edema) starting 5 days prior to SRS. Patients may be tapered to meet this criterion if deemed safe by the treating physician.
• •Women of child-bearing potential (e.g. not post-menopausal or permanently sterilized women) must have a negative pregnancy test obtained within 14 days prior to registration. This is to prevent potential harm to the fetus by glyburide and radiotherapy.
• •CBC with differential and CMP including Liver Function Tests (LFTs) obtained within 14 days prior to registration and meeting the following requirements:
• •* Creatinine Clearance ≥ 50 mL/min.
• •* Total Bilirubin \< 1.5 x the upper limit of normal (ULN).
• •* ALT and AST ≤ 2.5 x ULN.
• •* Glucose ≥ 80 mg/dL.
• •* Hemoglobin ≥ 7 mg/dL.
• •* Absolute Neutrophil Count \> 100 cells/mm3.
• •* Pretreatment Edema/Tumor ratio (≥ 35:1) as contoured on a baseline MRI obtained at most 60 days prior to registration. Patients are allowed to have Whole Brain Radiotherapy (WBRT) or corticosteroid use between the time of pretreatment MRI and SRS (as long as the corticosteroids can be safely tapered at least 5 days prior to the treatment planning MRI and WBRT is at least 4 days prior to registration).
• •* Greater than 40 pack year history of smoking cigarettes.
• •* Whole Brain Radiotherapy at least 4 days and no more than 1 year prior to registration.
• •* RPA Class III.