Brain and Central Nervous System Tumors, Seizure
Conditions
Keywords
seizure, adult anaplastic astrocytoma, adult diffuse astrocytoma, adult pineal gland astrocytoma, adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma, adult brain stem glioma, adult ependymoblastoma, adult medulloblastoma, adult supratentorial primitive neuroectodermal tumor (PNET), adult ependymoma, adult anaplastic ependymoma, adult anaplastic meningioma, adult anaplastic oligodendroglioma, adult oligodendroglioma, adult pineoblastoma, adult pineocytoma, adult mixed glioma, adult papillary meningioma, recurrent adult brain tumor, adult grade II meningioma
Brief summary
RATIONALE: Levetiracetam and pregabalin are drugs that treat seizures. It is not yet known which drug is more effective in treating seizures caused by primary brain tumors. PURPOSE: This randomized phase II trial is studying the side effects and how well levetiracetam or pregabalin work in treating seizures in patients undergoing chemotherapy and/or radiation therapy for primary brain tumors.
Detailed description
OBJECTIVES: * To determine the safety and efficacy of antiepileptic drug monotherapy comprising levetiracetam or pregabalin in treating seizures in patients undergoing chemotherapy and/or radiotherapy for primary brain tumors. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive levetiracetam. * Arm II: Patients receive pregabalin. Patients are followed at 2 weeks, 2 months, 6 months, and then at 1 year.
Interventions
DRUGlevetiracetam
After inclusion, patients receive Levetiracetam 2x250mg per day. The medication may be increased, in intervals of 500mg of Levetiracetam of at least 24h up to maximally: Levetiracetam 2x1500mg. Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study.
DRUGpregabalin
After inclusion, patients receive Pregabalin 2x75mg per day. The medication may be increased, in intervals of 150mg of Pregabalin of at least 24h up to maximally: Pregabalin 2x300mg. Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study.
Sponsors
Dr Andrea Rossetti
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of primary brain tumor * WHO grade II-IV disease * Undergoing chemotherapy and/or radiotherapy * No brain tumor without the potential need for chemotherapy (e.g., meningioma without anaplastic features) * Has had at least one seizure provoked by the brain tumor, justifying introduction of antiepileptic drug (AED) treatment * No status epilepticus PATIENT CHARACTERISTICS: * Modified Rankin score \< 4 at study enrollment * Life expectancy ≥ 4 weeks * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No known intolerance to the study drugs * No pre-existing psychosis and/or current suicidality PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent IV AEDs other than benzodiazepines * Other concurrent AEDs, except phenobarbital, allowed provided they are discontinued within 2 weeks after study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without occurrence of status epilepticus, 2 seizures with consciousness impairment, need to add a second antiepileptic drug (AED) (except transitory benzodiazepine), and need to discontinue study drug for lack of efficacy or adverse events | baseline to visit at 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety | baseline to visit at 12 months |
| Need to add a second AED | baseline to visit at 12 months |
| Adverse events | baseline to visit at 12 months |
| Occurrence of consciousness-impairing seizures or status epilepticus | baseline to visit at 12 months |
| Mortality | baseline to visit at 12 months |
| Study drug discontinuation | baseline to visit at 12 months |
Countries
Switzerland
Outcome results
None listed