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Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

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ClinicalTrials.gov Identifier: NCT00415376
Recruitment Status : Withdrawn (Unable to accrue subjects)
First Posted : December 22, 2006
Last Update Posted : May 18, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief 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.

Condition or disease Intervention/treatment
Brain and Central Nervous System Tumors Seizure Unspecified Adult Solid Tumor, Protocol Specific Drug: levetiracetam Procedure: quality-of-life assessment

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Supportive Care
Official Title: A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
Study Start Date : February 2007
Primary Completion Date : July 2007
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
U.S. FDA Resources

Primary Outcome Measures :
  1. Seizure control (lack of seizure activity)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415376

Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Principal Investigator: Jeffrey J. Raizer, MD Robert H. Lurie Cancer Center

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00415376     History of Changes
Other Study ID Numbers: CDR0000520380
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by Northwestern University:
adult tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neoplasms by Site
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs