Clinical trial NCT00629889: Levetiracetam or Pregabalin 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Seizure
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
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: baseline to visit at 12 months
Secondary outcomes:
measure: Adverse events
timeFrame: baseline to visit at 12 months
measure: Anxiety
timeFrame: baseline to visit at 12 months
measure: Need to add a second AED
timeFrame: baseline to visit at 12 months
measure: Study drug discontinuation
timeFrame: baseline to visit at 12 months
measure: Occurrence of consciousness-impairing seizures or status epilepticus
timeFrame: baseline to visit at 12 months
measure: Mortality
timeFrame: baseline to visit at 12 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zürich
country: Switzerland
facility: USZ
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Andrea O. Rossetti, MD
role: PRINCIPAL_INVESTIGATOR
References: