Phase
Condition
Neoplasm Metastasis
Treatment
Levetiracetam (Keppra)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a biopsy proven solid malignancy with at least oneintracranial lesion radiographically consistent with or pathologically proven to bea brain metastasis located in the primary motor cortex measuring 0.5 cm or larger inmaximal 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 clinicianand/or study PI
Ability to understand and the willingness to sign a written informed consentdocument by either ink on paper or a DF/HCC approved eConsent medium
Exclusion
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 prophylacticanti-seizure medication under study
Participants concurrently taking (i.e. at enrollment) an ASM for non-seizureindications 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/ dayor 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 thebrain, which is required to determine the presence of and follow the course of brainmetastases under study
Participants who cannot receive gadolinium as MRI of the brain with contrast isrequired
Participants with end stage renal disease due to risk of nephrogenic systemicfibrosis in this patient population after exposure to gadolinium-based contrastagents
Participants with widespread, definitive leptomeningeal disease given thatleptomeningeal disease and brain metastases are different entities
Pregnant women are excluded from this study because levetiracetam crosses theplacenta. In addition, the potential deleterious effects of gadolinium on thedeveloping fetus are not completely known
Women who are breastfeeding are excluded from this study because levetiracetamenters breast milk. In addition, the potential deleterious effects of gadolinium inbreast milk remain unknown
Study Design
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available

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