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
1 other identifier
interventional
73
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2016
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
June 28, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJune 28, 2016
June 1, 2016
2.9 years
June 14, 2016
June 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 months Progression free survival
from the first operation to following 6 months
Secondary Outcomes (1)
Overall survival
from the first operation to following 36 months
Study Arms (1)
Levetiracetam
OTHERNewly diagnosed histologically proven supratentorial glioblastoma patients received levetiracetam during and after their CCRT
Interventions
Patients in this group are with newly diagnosed glioblastoma patients who are supposed to be treated with concurrent chemoradiotherapy (CCRT) and adjuvant chemotherapy with temozolomide (TMZ). Patients ( intervention Group) will be given levetiracetam (LEV) from the beginning of treatment till after the adjuvant chemotherapy with TMZ is over.
Eligibility Criteria
You may qualify if:
- 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.
- Age 20 -76 years
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2
- Meets 1 of the following RPA classifications:
- 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)
- 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
- Written informed consent
You may not qualify if:
- Prior chemotherapy within last 5 years
- Prior radiotherapy of the head and neck area
- Receiving concurrent investigational agents or has received an investigational agent within 30 days prior to randomization
- Planned surgery for other diseases (e.g. dental extraction)
- 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
- Pregnant or lactating women
- Subject who disagree to follow acceptable methods of contraception
- Concurrent illness including unstable heart disease despite appropriate treatment, history of myocardial infarction within 6 months, serious neurological or psychological disease, and uncontrolled infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Kim 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: 25975354BACKGROUNDGuthrie 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: 23176328BACKGROUNDKerkhof 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: 23680820BACKGROUNDHwang 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: 34845868DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chae-Yong Kim, PhD
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 14, 2016
First Posted
June 28, 2016
Study Start
July 1, 2016
Primary Completion
June 1, 2019
Study Completion
June 1, 2022
Last Updated
June 28, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share