Validation of the Role of Levetiracetam for Newly Diagnosed GBM Patients

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Etiracetam; Levetiracetam; Piracetam; Temozolomide

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