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Validation of the Role of Levetiracetam for Newly Diagnosed GBM Patients

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 20 Years - 76 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02815410

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Seoul National University Hospital

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Chae-Yong Kim, PhD
Principal Investigator Affiliation Seoul National University Bundang Hospital

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Not yet recruiting
Countries

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Glioblastoma Multiforme
Additional Details

  • I. Objectives 6 months progression-free survival (6m-PFS) 1.
Overall survival 2. Safety (adverse events) 3. Quality of life using EORTC module, 4. Cognitive function using NOPT module of our institution Genetic biomarker for predicting prognosis 1. Methylation status of MGMT promoter 2. IDH mutation 3. TERT mutation / ATRX status
  • II. Hypothesis 1.
Proof of concept
  • - With using of levetiracetam, there will be an improved survival with chemoradiotherapy with temozolomide compared to the group without using levetiracetam.
(superiority) 2. Safety
  • - It will be tolerable in this concept.
3. Genetic biomarker
  • - Methylation status of MGMT, IDH1 mutation, TERT mutation, and ATRX status will prove to be valid molecular markers of prognostic significance in newly diagnosed glioblastoma treated with the combination of levetiracetam.
  • III. Study Design/Clinical Plan 1.
Group I (prospective)
  • - 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 in Group I will be given levetiracetam (LEV) from the beginning of treatment till after the adjuvant chemotherapy with TMZ is over. 2. Group II (historical group; using data base from KSNO multicenter study group)
  • IV. Treatment 1.
Levetiracetam: started with 250mg bid and is increased up to 500mg bid in perioperative period. During the 2 days of peri-operation, it is administered in intravenous form mixed in 150ml of normal saline. After immediate postoperative period, 500~1500mg bid is administered in per oral form according to patient's clinical condition. During the period of adjuvant chemotherapy with temozolomide, the dose not less than 500mg is administered unless there are serious side effects of levetiracetam. 2. Temozolomide based standard treatment: CCRT with temozolomide followed by 6cycles of adjuvant temozolomide RT with daily temozolomide (75 mg/m2/day, 7 days/week) from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg/m2 for 5 days during each 28-day cycle).
  • V. Evaluation MR scans were performed before the first adjuvant treatment cycle and then every 3 months during the first year, and every 4 months during the second year.
Radiographic response is determined in comparison to the tumor measurement obtained at pretreatment baseline measurements as a reference and is categorized into four groups using new criteria proposed by the Response Assessment in Neuro-Oncology (RANO) working group.
  • VI. Statistical Plans Total sample size: 73 The size of sample is considered by assessment of PFS.
The number of event and statistical power was calculated on assumption of exponential distribution of the 7 months median PFS in the control group and 12 months median PFS in the treatment group. The expected sample size provides 80% of test power that can perceive 1.7 of hazard ration with 0.05 of type I error in comparative analysis of PFS at the time of 12 months of registering period (in equal entry pattern) and at 6 months of follow up period. Basis on this assumption, it is expected that 73 patients are needed in the treatment group, and 74 patients in the control group.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Chae-Yong Kim, PhD

chaeyong@snu.ac.kr

+82-31-787-7165

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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