Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
RATIONALE: Anticonvulsant drugs, such as levetiracetam, may help control seizures caused by brain metastases.
PURPOSE: This clinical trial is studying the side effects and how well levetiracetam works in treating patients with seizures caused by brain metastases.
|Brain and Central Nervous System Tumors Seizure Unspecified Adult Solid Tumor, Protocol Specific||Drug: levetiracetam Procedure: quality-of-life assessment|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases|
- Seizure control (lack of seizure activity)
|Study Start Date:||February 2007|
|Estimated Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- 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 physician.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415376
|Principal Investigator:||Jeffrey J. Raizer, MD||Robert H. Lurie Cancer Center|