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Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
levetiracetam
quality-of-life assessment
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring seizure, adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Seizure control (lack of seizure activity)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2006
    Last Updated
    May 17, 2012
    Sponsor
    Northwestern University
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00415376
    Brief Title
    Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
    Official Title
    A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Unable to accrue subjects
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    July 2007 (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Northwestern University
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain and Central Nervous System Tumors, Seizure, Unspecified Adult Solid Tumor, Protocol Specific
    Keywords
    seizure, adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    levetiracetam
    Intervention Type
    Procedure
    Intervention Name(s)
    quality-of-life assessment
    Primary Outcome Measure Information:
    Title
    Seizure control (lack of seizure activity)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffrey J. Raizer, MD
    Organizational Affiliation
    Robert H. Lurie Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

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