Clinical trial · Interventional
Validation of the Role of Levetiracetam for Newly Diagnosed GBM Patients
The Prospective Trial for Validation of the Role of Levetiracetam as a Sensitizer of Temozolomide in the Treatment of Newly Diagnosed Glioblastoma Patients
NCT02815410CI-TRIAL-00022759unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective, open-labeled, multicenter cohort trial for validation of the role of levetiracetam as a sensitizer of temozolomide in the treatment of newly diagnosed glioblastoma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| levetiracetam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Levetiracetam
- description
- Newly diagnosed histologically proven supratentorial glioblastoma patients received levetiracetam during and after their CCRT
- interventionNames
- Drug: levetiracetam
Primary outcomes (1)
- measure
- 6 months Progression free survival
- timeFrame
- from the first operation to following 6 months
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- from the first operation to following 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization \[WHO\] Grade IV). The histological diagnosis must be obtained from a neurosurgical resection or biopsy of a tumor including an open biopsy or stereotactic biopsy. 2. Age 20 -76 years 3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2 4. Meets 1 of the following RPA classifications: 4-1. Class III (Age \<50 years and ECOG PS 0) 4-2. Class IV (meeting one of the following criteria: a) Age \<50 years and ECOG PS 1 or b) Age ≥50 years, underwent prior partial or total tumor resection, MMSE ≥27) 4-3. Class V (meeting one of the following criteria: a) Age ≥50 years and underwent prior partial or total tumor resection, MMSE \<27 or b) Age ≥50 years and underwent prior tumor biopsy only) 5. Adequate hematologic, renal, and hepatic function: ANC \> 1,500/uL Platelet \> 100,000/uL Serum creatinine \<1.7mg/dL Bilirubin level \< 2.0 mg/dL AST/ALT \< 2.5 x upper limit of normal range of each institution 6. Written informed consent Exclusion Criteria: 1. Prior chemotherapy within last 5 years 2. Prior radiotherapy of the head and neck area 3. Receiving concurrent investigational agents or has received an investigational agent within 30 days prior to randomization 4. Planned surgery for other diseases (e.g. dental extraction) 5. History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for 5 years are eligible for this study 6. Pregnant or lactating women 7. Subject who disagree to follow acceptable methods of contraception 8. Concurrent illness including unstable heart disease despite appropriate treatment, history of myocardial infarction within 6 months, serious neurological or psychological disease, and uncontrolled infection
References
Publications (4)
- BACKGROUNDKim YH, Kim T, Joo JD, Han JH, Kim YJ, Kim IA, Yun CH, Kim CY. Survival benefit of levetiracetam in patients treated with concomitant chemoradiotherapy and adjuvant chemotherapy with temozolomide for glioblastoma multiforme. Cancer. 2015 Sep 1;121(17):2926-32. doi: 10.1002/cncr.29439. Epub 2015 May 14. PMID 25975354
- BACKGROUNDGuthrie GD, Eljamel S. Impact of particular antiepileptic drugs on the survival of patients with glioblastoma multiforme. J Neurosurg. 2013 Apr;118(4):859-65. doi: 10.3171/2012.10.JNS12169. Epub 2012 Nov 23. PMID 23176328
- BACKGROUNDKerkhof M, Dielemans JC, van Breemen MS, Zwinkels H, Walchenbach R, Taphoorn MJ, Vecht CJ. Effect of valproic acid on seizure control and on survival in patients with glioblastoma multiforme. Neuro Oncol. 2013 Jul;15(7):961-7. doi: 10.1093/neuonc/not057. Epub 2013 May 16. PMID 23680820
- DERIVEDHwang K, Kim J, Kang SG, Jung TY, Kim JH, Kim SH, Kang SH, Hong YK, Kim TM, Kim YJ, Choi BS, Chang JH, Kim CY. Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open-label phase 2 study. Cancer Med. 2022 Jan;11(2):371-379. doi: 10.1002/cam4.4454. Epub 2021 Nov 30. PMID 34845868