Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

• NCT number: NCT00415376
• Study type: Interventional
• Source: Northwestern University
• Status: Withdrawn
• Phase: N/A
• Start date: February 2007
• Completion date: July 2007