levetiracetam in treating patients with seizures caused by brain metastases

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

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.

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.

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

Keywords: seizure adult tumors metastatic to brain unspecified adult solid tumor, protocol specific