Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors

Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.

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.

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.

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