Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases - Full Text View

Sponsors and Collaborators:	Robert H. Lurie Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00415376

Purpose

RATIONALE: Anticonvulsant drugs, such as levetiracetam, may help control seizures caused by brain metastases.

PURPOSE: This clinical trial is studying the side effects and how well levetiracetam works in treating patients with seizures caused by brain metastases.

Condition	Intervention
Brain and Central Nervous System Tumors Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific	Drug: levetiracetam Procedure: quality-of-life assessment

Genetics Home Reference related topics: pyridoxine-dependent epilepsy

MedlinePlus related topics: Cancer Seizures

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care
Official Title:	A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases

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

Primary Outcome Measures:

Seizure control (lack of seizure activity)

Estimated Enrollment:	30
Study Start Date:	February 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the optimal dose of levetiracetam required to control seizures from brain metastases in patients with solid tumors.
Determine the frequency of side effects and tolerability of this drug when used to control seizures in these patients.
Determine any improvement in antiepileptic drug-associated symptoms in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to baseline seizures (yes vs no) and/or baseline antiepileptic drugs (AEDs) (yes vs no). Patients are assigned to 1 of 3 treatment groups.

Group I (patients with no active baseline seizures): Patients receive oral levetiracetam twice daily beginning on day 1.
Group II (patients requiring IV AEDs for baseline seizure control): Patients receive oral levetiracetam (instead of their current anticonvulsant therapy) twice daily beginning on day 1, after their presenting condition has stabilized.
Group III (patients with active seizures controlled by other concurrent anticonvulsant monotherapy): Patients receive oral levetiracetam (instead of their current anticonvulsant therapy) twice daily beginning on day 1. Treatment with the other anticonvulsant drug is tapered beginning on day 3 as directed by the treating physician.

In all groups, treatment continues for up to 6 months in the absence of uncontrolled seizures or unacceptable toxicities.

During study therapy, patients maintain a seizure log that tracks frequency and type of seizures. Any patient who experiences a breakthrough seizure or multiple auras receives increasing doses of oral levetiracetam until the maximum dose is reached. Patients who continue to have seizures at the maximum dose level receive a second antiseizure medication at the discretion of the treating physician.

Quality of life is assessed by the Fundamental Assessment of Cancer Treatment-Brain questionnaire at baseline and at 2 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed solid tumor
- Pathological confirmation of brain metastasis is not required provided the clinical and neuroradiographic picture is typical
Has had at least one prior seizure due to brain metastasis

PATIENT CHARACTERISTICS:

Life expectancy ≥ 12 weeks
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10 g/dL
BUN < 5 times upper limit of normal (ULN)
Creatinine < 5 times ULN
Bilirubin < 1.5 times ULN
AST and ALT ≤ 3 times ULN
Alkaline phosphatase ≤ 2 times ULN
No allergy to levetiracetam

PRIOR CONCURRENT THERAPY:

Prior levetiracetam allowed provided it was initiated within the past 14 days
Other concurrent anticonvulsant monotherapy allowed provided therapy was initiated within the past 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415376

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Robert H. Lurie Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jeffrey J. Raizer, MD

Robert H. Lurie Cancer Center

More Information

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

Study ID Numbers:	CDR0000520380, NU-05CC11, NU-1398-032, UCB-NU-05CC11
Study First Received:	December 20, 2006
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00415376
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

seizure
adult tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Seizures
Neoplasm Metastasis
Etiracetam
Central Nervous System Neoplasms
Nervous System Neoplasms

Additional relevant MeSH terms:

Nootropic Agents
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

Therapeutic Uses
Nervous System Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009