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
Unspecified Adult Solid Tumor, Protocol Specific
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|