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Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

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Northwestern University

Status

Withdrawn

Conditions

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

Treatments

Procedure: quality-of-life assessment
Drug: levetiracetam

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00415376
NU-05CC11
CDR0000520380
UCB-NU-05CC11
NU-1398-032

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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