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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by VU University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Medical Center Haaglanden
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00454935
First received: March 30, 2007
Last updated: June 6, 2008
Last verified: June 2008
  Purpose

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 Phase
Epilepsy
Glioma
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • 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). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood Tumor tissue


Estimated Enrollment: 40
Study Start Date: April 2007
Estimated Study Completion Date: October 2008
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.

  Eligibility

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

Consecutive adult (> 18 years) glioma patients who suffer from partial seizures, with or without secondary generalisation, preoperatively. Patients must have undergone surgery for their newly diagnosed or recurrent glioma not more than 42 days previously and be treated with levetiracetam monotherapy at the time of inclusion.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454935

Contacts
Contact: J.C. Reijneveld, dr +(31)20-4442821 jc.reijneveld@vumc.nl

Locations
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: J.J. Reijneveld, dr    +(31)20-4442821    jc.reijneveld@vumc.nl   
Principal Investigator: S.T. Toering, drs         
Sponsors and Collaborators
VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Medical Center Haaglanden
Investigators
Study Chair: J.J. Heimans, prof. dr. VU University Medical Center
  More Information

No publications provided

Responsible Party: Prof Dr J.J. Heimans, VU University Medical Centre
ClinicalTrials.gov Identifier: NCT00454935     History of Changes
Other Study ID Numbers: EPI-GLIO-LEV
Study First Received: March 30, 2007
Last Updated: June 6, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by VU University Medical Center:
epilepsy
glioma

Additional relevant MeSH terms:
Glioma
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Etiracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents

ClinicalTrials.gov processed this record on August 28, 2014