Brain and Central Nervous System Tumors, Seizure, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
seizure, adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific
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.
Interventions
DRUGlevetiracetam
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
Northwestern University
Study design
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure control (lack of seizure activity) | — |
Outcome results
None listed