NCT00415376

Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Brain and Central Nervous System Tumors
• Seizure
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	levetiracetam
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2006-12-22
• Last updated: 2012-05-18