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

Condition(s) targeted: Brain and Central Nervous System Tumors; Seizure

Intervention: levetiracetam (Drug); pregabalin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Centre Hospitalier Universitaire Vaudois

Official(s) and/or principal investigator(s):
Andrea O. Rossetti, MD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire Vaudois

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.

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

Study design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: 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

Secondary outcome:

Adverse events

Anxiety

Need to add a second AED

Study drug discontinuation

Occurrence of consciousness-impairing seizures or status epilepticus

Mortality

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Centre Hospitalier Universitaire Vaudois, Lausanne CH-1011, Switzerland; Recruiting
Andrea O. Rossetti, MD, Phone: 41-21-314-1220

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: February 2008
Last updated: November 10, 2009