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

Sponsored by:	Centre Hospitalier Universitaire Vaudois
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00629889

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors Seizure	Drug: levetiracetam Drug: pregabalin	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label
Official Title:	Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Brain Cancer Cancer Radiation Therapy Seizures

Drug Information available for: Levetiracetam Pregabalin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse events [ Designated as safety issue: Yes ]
Anxiety [ Designated as safety issue: No ]
Need to add a second AED [ Designated as safety issue: No ]
Study drug discontinuation [ Designated as safety issue: No ]
Occurrence of consciousness-impairing seizures or status epilepticus [ Designated as safety issue: No ]
Mortality [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629889

Locations

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

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators

Principal Investigator:

Andrea O. Rossetti, MD

Centre Hospitalier Universitaire Vaudois

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000586523, CHUV-Neurology-CePO-LEV/PGB, EU-20807
Study First Received:	March 5, 2008
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00629889 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Glioblastoma
Neuroectodermal Tumors, Primitive
Central Nervous System Neoplasms
Brain Diseases
Ependymoma
Signs and Symptoms
Neuroepithelioma
Meningioma
Analgesics
Glioma
Nervous System Neoplasms
Nootropic Agents
Astrocytoma
Seizures

Central Nervous System Diseases
Pregabalin
Recurrence
Neuroectodermal Tumors
Brain Neoplasms
Epilepsy
Medulloblastoma
Neurologic Manifestations
Oligodendroglioma
Etiracetam
Peripheral Nervous System Agents
Gliosarcoma
Pinealoma
Anticonvulsants

Additional relevant MeSH terms:

Nootropic Agents
Physiological Effects of Drugs
Seizures
Nervous System Diseases
Pregabalin
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Pharmacologic Actions
Brain Neoplasms
Signs and Symptoms
Neoplasms

Neoplasms by Site
Sensory System Agents
Epilepsy
Therapeutic Uses
Neurologic Manifestations
Etiracetam
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants
Nervous System Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009