Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: levetiracetam
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levetiracetam|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure control (lack of seizure activity) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seizure, adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific