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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00454935
• Other study ID #: EPI-GLIO-LEV
• Status: Recruiting
• Phase: Phase 4
• First received: March 30, 2007
• Last updated: June 6, 2008
• Start date: April 2007
• Est. completion date: October 2008

Study information

• Verified date: June 2008
• Source: VU University Medical Center
• Contact: J.C. Reijneveld, dr
• Phone: +(31)20-4442821
• Email: jc.reijneveld[@]vumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy
• Glioma

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam

Sponsors (3)

Lead Sponsor	Collaborator
VU University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Medical Center Haaglanden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No