Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
Recruitment status was Recruiting
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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.
| 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 |
- 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 ]
- 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 |
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 |
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.
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| Contact: J.C. Reijneveld, dr | +(31)20-4442821 | jc.reijneveld@vumc.nl |
| 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 | |
| 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 May 16, 2013