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Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy

Sponsor
Amsterdam UMC, location VUmc (Other)
Overall Status
Unknown status
CT.gov ID
NCT00454935
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other), Medical Center Haaglanden (Other)
40
Enrollment
1
Location
18
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Levetiracetam is a relatively novel anti-epileptic drug (AED), which has proven to be effective and well tolerated in many glioma patients with otherwise pharmacoresistant epilepsy. Moreover, levetiracetam has neither enzyme-inducing nor enzyme-inhibiting properties, which makes the drug particularly attractive for brain tumour patients, as they frequently receive chemotherapy and/or corticosteroids. Therefore, levetiracetam is the anti-epileptic drug of choice post-operatively in glioma patients suffering from epilepsy. Unfortunately, even with levetiracetam, a proportion of glioma patients is not free of seizures. It is unclear, however, which glioma patients benefit from levetiracetam treatment. It is suggested that the expression of protein SV2A is correlated with clinical response to levetiracetam. The determination of SV2A expression in brain (tumour) tissue might be used as a predictive tool for response to levetiracetam.

    Objective of this study: Correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
    Study Start Date :
    Apr 1, 2007
    Anticipated Study Completion Date :
    Oct 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. to correlate the efficacy of post-operative levetiracetam monotherapy in newly diagnosed glioma patients suffering from epilepsy with expression of synaptic vesicle protein 2A (SV2A). [6 months]

    Secondary Outcome Measures

    1. to determine the impact of levetiracetam monotherapy on neurocognitive functioning, health-related quality of life, and epileptic brain activity as measured by MEG, in newly diagnosed glioma patients with epilepsy [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age > 18 years

    • suffering from partial seizures, with or without secondary generalisation

    • must have undergone surgery for their newly diagnosed or recurrent glioma not more than 42 days previously

    • treated with levetiracetam

    • histologically proven astrocytoma grade II or III, oligodendroglioma grade II or III, oligoastrocytoma grade II or III, or glioblastoma multiforme according to the World Health Organisation (WHO) classification of tumours affecting the central nervous system

    • written informed consent

    Exclusion Criteria:

    • Women who are pregnant or lactating

    • Patients who do not have a basic proficiency of the Dutch language,or are unable to communicate adequately will also be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VU University Medical Center Amsterdam Netherlands 1081 HV

    Sponsors and Collaborators

    • Amsterdam UMC, location VUmc
    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    • Medical Center Haaglanden

    Investigators

    • Study Chair: J.J. Heimans, prof. dr., Amsterdam UMC, location VUmc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00454935
    Other Study ID Numbers:
    • EPI-GLIO-LEV
    First Posted:
    Apr 2, 2007
    Last Update Posted:
    Jun 9, 2008
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    epilepsy
    glioma
    Additional relevant MeSH terms:
    Glioma
    Epilepsy

    Study Results

    No Results Posted as of Jun 9, 2008