Status:
TERMINATED
Seizure Prophylaxis in Patients With Glioma or Brain Metastasis
Lead Sponsor:
Duke University
Conditions:
Glioma
Glioma of Brain
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
This protocol is designed to assess the need for seizure prophylaxis in the perioperative period for patients undergoing neurosurgical procedure (gross-total resection, sub-total resection or biopsy) ...
Detailed Description
The protocol will assess the need for AED prophylaxis during the post-operative period in patients undergoing neurosurgical procedure for a suspected diagnosis of glioma (WHO grade I-IV) and brain met...
Eligibility Criteria
Inclusion
- Patients with a suspected diagnosis of new, recurrent, or transformed glioma (WHO grade I-IV) or brain metastasis scheduled for neurosurgical procedure (gross-total resection, sub-total resection or biopsy) at Duke University Medical Center (DUMC);
- Safe for surgery per treating neurosurgeon;
- Due to the potential implications of the treatment on the developing central nervous system (CNS), all patients must be ≥ 18 years of age at the time of entry into the study;
- Laboratory Studies:
- Total bilirubin, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), Alkaline Phosphatase (ALK) ≤ 1.5 x upper limit of normal (ULN)
- Creatinine ≤ 1.5
- A signed informed consent form approved by the Duke University Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study.
- Patients of child bearing potential or with partners of child-bearing potential must agree to practice recommended contraceptive methods to prevent pregnancy during treatment and for 1 month after the last dose of AED for women and men.
Exclusion
- Pregnant or need to breast feed during the study period (Negative urine β-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study and for 1 month after the last dose of AED;
- Patients already on AED(s);
- Known history of epilepsy/seizure disorder;
- Known history of dependency/abuse of psychopharmaceuticals, alcohol, illicit drugs or narcotics;
- Any significant medical or psychiatric illness that cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate therapy, per the discretion of the treating investigator;
- Known allergy to LCM or LEV.
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03436433
Start Date
January 31 2019
End Date
December 4 2020
Last Update
April 13 2023
Active Locations (1)
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1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710