Levetiracetam for the Prevention of Seizures in Patients with Solid Tumors and Brain Metastases in the Primary Motor Cortex

Inclusion Criteria

• Participants must have a biopsy proven solid malignancy with at least one intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis located in the primary motor cortex measuring 0.5 cm or larger in maximal unidimensional size
• Age of at least 18 years
• Karnofsky performance status of at least 60
• Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study principal investigator (PI)
• Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a Dana-Farber/Harvard Cancer Center (DF/HCC) approved electronic consent (eConsent) medium

Exclusion Criteria

• Participants with prior seizures as this is a study for seizure-naïve patients
• Participants with an allergy to levetiracetam as levetiracetam is the prophylactic ASM medication under study
• Participants concurrently taking (i.e. at enrollment) an ASM for non-seizure indications at clinically relevant doses (gabapentin 1800 mg/day or higher, pregabalin 300 mg/day or higher, lamotrigine 150 mg/day or higher, valproic acid 1000 mg/day or higher, topiramate 200 mg/day or higher, carbamazepine 200 mg/day or higher, oxcarbazepine 300 mg/day or higher, primidone 100 mg/day or higher) because use of these medications could bias the study toward the null
• Participants who cannot tolerate a magnetic resonance imaging (MRI) study of the brain, which is required to determine the presence of and follow the course of brain metastases under study
• Participants who cannot receive gadolinium as MRI of the brain with contrast as contrast is required to fully visualize the extent of disease
• Participants with end stage renal disease due to risk of nephrogenic systemic fibrosis in this patient population after exposure to gadolinium-based contrast agents
• Participants with widespread, definitive leptomeningeal disease given that leptomeningeal disease and brain metastases are different entities
• Pregnant women are excluded from this study because levetiracetam crosses the placenta. In addition, the potential deleterious effects of gadolinium on the developing fetus are not completely known
• Women who are breastfeeding are excluded from this study because levetiracetam enters breast milk. In addition, the potential deleterious effects of gadolinium in breast milk remain unknown