A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
- Determine the optimal dose of levetiracetam required to control seizures from brain
metastases in patients with solid tumors.
- Determine the frequency of side effects and tolerability of this drug when used to
control seizures in these patients.
- Determine any improvement in antiepileptic drug-associated symptoms in these patients.
OUTLINE: This is a pilot study. Patients are stratified according to baseline seizures (yes
vs no) and/or baseline antiepileptic drugs (AEDs) (yes vs no). Patients are assigned to 1 of
3 treatment groups.
- Group I (patients with no active baseline seizures): Patients receive oral
levetiracetam twice daily beginning on day 1.
- Group II (patients requiring IV AEDs for baseline seizure control): Patients receive
oral levetiracetam (instead of their current anticonvulsant therapy) twice daily
beginning on day 1, after their presenting condition has stabilized.
- Group III (patients with active seizures controlled by other concurrent anticonvulsant
monotherapy): Patients receive oral levetiracetam (instead of their current
anticonvulsant therapy) twice daily beginning on day 1. Treatment with the other
anticonvulsant drug is tapered beginning on day 3 as directed by the treating
In all groups, treatment continues for up to 6 months in the absence of uncontrolled
seizures or unacceptable toxicities.
During study therapy, patients maintain a seizure log that tracks frequency and type of
seizures. Any patient who experiences a breakthrough seizure or multiple auras receives
increasing doses of oral levetiracetam until the maximum dose is reached. Patients who
continue to have seizures at the maximum dose level receive a second antiseizure medication
at the discretion of the treating physician.
Quality of life is assessed by the Fundamental Assessment of Cancer Treatment-Brain
questionnaire at baseline and at 2 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Primary Purpose: Supportive Care
Seizure control (lack of seizure activity)
Jeffrey J. Raizer, MD
Robert H. Lurie Cancer Center
United States: Federal Government