Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

Last updated: May 17, 2012
Sponsor: Northwestern University
Overall Status: Trial Not Available

Phase

N/A

Condition

Cataplexy

Neoplasms

Treatment

N/A

Clinical Study ID

NCT00415376
CDR0000520380
NU-05CC11
NU-1398-032
UCB-NU-05CC11
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor

  • Pathological confirmation of brain metastasis is not required provided the clinical and neuroradiographic picture is typical

  • Has had at least one prior seizure due to brain metastasis

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 12 weeks

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception

  • Absolute neutrophil count ≥ 1,500/mm³

  • Platelet count ≥ 100,000/mm³

  • Hemoglobin ≥ 10 g/dL

  • BUN < 5 times upper limit of normal (ULN)

  • Creatinine < 5 times ULN

  • Bilirubin < 1.5 times ULN

  • AST and ALT ≤ 3 times ULN

  • Alkaline phosphatase ≤ 2 times ULN

  • No allergy to levetiracetam

PRIOR CONCURRENT THERAPY:

  • Prior levetiracetam allowed provided it was initiated within the past 14 days

  • Other concurrent anticonvulsant monotherapy allowed provided therapy was initiated within the past 30 days

Study Design

Study Start date:
February 01, 2007
Estimated Completion Date:
July 31, 2007

Study 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.