Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Seizure Treatment in Glioma (STING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03048084
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
Medical Center Haaglanden
Erasmus Medical Center
VU University Medical Center
Information provided by (Responsible Party):
j.a.f.koekkoek, Leiden University Medical Center

Brief Summary:
Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure.

Condition or disease Intervention/treatment Phase
Glioma Drug: Levetiracetam Drug: Valproic Acid Phase 4

Detailed Description:

Currently, treatment of glioma patients with a specific anti-epileptic drug (AED) mainly depends on the physicians' preference, as there is no robust evidence from randomized controlled trials supporting the use of one specific anticonvulsant above the other in glioma patients.

Levetiracetam and valproic acid are the most commonly used AEDs in glioma patients. Both drugs are used for the treatment of seizures, have similar toxicity profiles and are non-enzyme inducing AEDs, therefore not interfering with chemotherapeutic drugs. However, it is not known whether one drug is more effective than the other in reducing seizures.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Seizure Treatment IN Glioma (STING): Comparing a Treatment Strategy With Levetiracetam Versus Treatment With Valproic Acid in Glioma Patients With a First Seizure
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2022


Arm Intervention/treatment
Active Comparator: Levetiracetam
Patients in this treatment arm will receive levetiracetam monotherapy. The dosage depends on the specific treatment step, as indicated in the protocol. In step 1, patients will receive 2x500 mg/d levetiracetam in the form of tablets. In step 2, dosage is increased to 1x250 plus 1x500 mg/d and in step 3 to 2x1000 mg/d levetiracetam. In step 4, levetiracetam is increased to 2x1500mg/d. In the fifth treatment step, patients will receive 2x1500 mg/d levetiracetam, and another AED will be added. The type and dosage of this add-on AED is according to the physician's preference, but in line with current clinical practice in the Netherlands.
Drug: Levetiracetam
Antiepileptic drug levetiracetam
Other Name: Keppra

Active Comparator: Valproic acid
Patients in this treatment arm will receive valproic acid monotherapy. The dosage depends on the specific treatment step, as indicated in the protocol. In step 1, patients will receive 2x500 mg/d valproic acid in the form of tablets. In step 2, dosage is increased to 1x250 plus 1x500 mg/d and in step 3 to 2x1000 mg/d valproic acid. In step 4, valproic acid dosage is increased to a maximum of 2x1250mg/d. In the fifth treatment step, patients will receive 2x1250mg valproic acid, and another AED will be added. The type and dosage of this add-on AED is according to the physician's preference, but in line with current clinical practice in the Netherlands.
Drug: Valproic Acid
Antiepileptic drug valproic acid
Other Name: Depakine




Primary Outcome Measures :
  1. Ongoing seizure freedom at 6 months [ Time Frame: 6 months ]
    The percentage of patients with ongoing seizure freedom at 6 months


Secondary Outcome Measures :
  1. Time to 6 months seizure freedom [ Time Frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    Time to 6 months seizure freedom

  2. Seizure outcome at 12 months [ Time Frame: 12 months ]
    Seizure outcome at 12 months

  3. Toxicity [ Time Frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    Adverse effects of the treatment

  4. Hospitalisation rate [ Time Frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    hospitalization rate due to treatment failure

  5. Health-related quality of life [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    Health-related quality of life

  6. Cognitive complaints [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    Cognitive complaints

  7. Mood [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    Anxiety and depression

  8. Performance Status [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    Karnofsky Performance Status Score

  9. Epilepsy burden [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    Epilepsy burden

  10. Treatment response [ Time Frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    Treatment response (e.g., maximum dosage of AED, use of add-on AED)

  11. Progression-free survival [ Time Frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    Progression-free survival

  12. Overall survival [ Time Frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively ]
    Overall survival



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven or suspected diffuse astrocytoma (Isocytrate Dehydrogenase-1 (IDH-1) wildtype or IDH-1 mutated), diffuse oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), anaplastic astrocytoma (IDH-1 wildtype or IDH-1 mutated), anaplastic oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), glioblastoma (IDH-1 wild-type or IDH-1 mutated), or diffuse astrocytoma not otherwise specified (NOS), anaplastic astrocytoma NOS, oligodendroglioma NOS, oligoastrocytoma NOS, anaplastic oligoastrocytoma NOS, anaplastic oligodendroglioma NOS or glioblastoma NOS.
  • Adult patients: ≥18 years of age
  • First epileptic seizure, no longer than 2 weeks ago
  • Monotherapy with antiepileptic drugs is considered most appropriate at the time of randomization
  • Willing to provide written informed consent

Exclusion Criteria:

  • Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks
  • History of non-brain tumor related epilepsy
  • Pregnancy
  • Presence of contra-indications for use of levetiracetam or valproic acid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048084


Contacts
Layout table for location contacts
Contact: Johan AF Koekkoek, MD, PhD 0031715269111 j.a.f.koekkoek@lumc.nl
Contact: Linda Dirven, PhD 0031715296735 l.dirven@lumc.nl

Locations
Layout table for location information
Netherlands
VU University Medical Center Not yet recruiting
Amsterdam, Netherlands, 1007 MB
Contact: Jaap C Reijneveld, MD, PhD    0031204442834    jc.reijneveld@vumc.nl   
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Johan AF Koekkoek, MD, PhD    0031715269111    j.a.f.koekkoek@lumc.nl   
Erasmus Medical Center Not yet recruiting
Rotterdam, Netherlands, 3008 AE
Contact: Martin J van den Bent, MD, PhD    0031107040704    m.vandenbent@erasmusmc.nl   
Haaglanden Medical Center Recruiting
The Hague, Netherlands, 2501 CK
Contact: Martin JB Taphoorn, MD, PhD    0031703302000    m.taphoorn@haaglandenmc.nl   
Sponsors and Collaborators
Leiden University Medical Center
Medical Center Haaglanden
Erasmus Medical Center
VU University Medical Center

Layout table for additonal information
Responsible Party: j.a.f.koekkoek, MD PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT03048084     History of Changes
Other Study ID Numbers: 77353
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Levetiracetam
Glioma
Seizures
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Valproic Acid
Anticonvulsants
Nootropic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs