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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Andrea Rossetti
• Treatments: Etiracetam; Levetiracetam; Piracetam; Pregabalin

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