Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
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.
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.
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