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Seizure Prophylaxis in Patients With Glioma or Brain Metastasis

Primary Purpose

Glioma, Glioma of Brain, Brain Tumor

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lacosamide

Levetiracetam

About this trial

This is an interventional treatment trial for Glioma focused on measuring anti-epileptic drugs, seizure prophylaxis, levetiracetam

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. Total bilirubin, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), Alkaline Phosphatase (ALK) ≤ 1.5 x upper limit of normal (ULN)
2. 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 Criteria:

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.

Sites / Locations

Duke Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Lacosamide

Levetiracetam

No anti-epileptic

Arm Description

Enrolled subjects will be randomized to receive Lacosamide.

Enrolled subjects will be randomized to receive Levetiracetam.

Enrolled subjects will be randomized to not receive anti-epileptic drugs.

Outcomes

Primary Outcome Measures

Percentage of Patients With an ED Visit/Hospital Readmission Within 30 Days of Craniotomy

The primary objective of this study is to assess the impact of LCM, LEV or, no AED in patients undergoing craniotomy for suspected new, recurrent or transformed glioma (WHO Gr I-IV) or brain metastasis on ED visits and readmissions within 30 days of craniotomy.

Secondary Outcome Measures

Number of Participants With an Adverse Event Within First 30 Days After Craniotomy

Adverse events related to LCM, LEV, and no drug within first 30 days after craniotomy.

Full Information

NCT ID

NCT03436433

First Posted

February 12, 2018

Last Updated

April 11, 2023

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03436433

Brief Title

Seizure Prophylaxis in Patients With Glioma or Brain Metastasis

Official Title

Phase II Trial of Seizure Prophylaxis in Brain Tumor Patients Undergoing Neurosurgical Procedure

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Terminated

Why Stopped

Did not enroll as planned

Study Start Date

January 31, 2019 (Actual)

Primary Completion Date

December 4, 2020 (Actual)

Study Completion Date

December 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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) for suspected diagnosis of new, recurrent or transformed glioma (WHO grade I-IV) and brain metastasis. This will be determined by observing the impact of Lacosamide (LCM), Levetiracetam (LEV), or no anti-epileptic drug (AED) on whether visits to the emergency department (ED) or hospital re-admissions occur within 30 days after procedure. A secondary endpoint will evaluate the safety and tolerability of LCM and LEV. Exploratory endpoints will evaluate admission duration for the procedure, number of post-operative provider communications (telephone, email, and additional clinic encounters, etc.), and patient risk factors associated with post-operative seizure.

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 metastasis. Patients (n=116) will be consented and randomized at their pre-operative assessment, either at their pre-operative clinic visit or in the ED, if that is the time of their initial presentation prior to surgery. There will be three arms to the study - patients will be randomized to LCM, LEV, or control (no AED). Randomization will be stratified by suspected grade (LGG vs HGG) and brain metastasis. The AED can be initiated anytime within 48 hours before neurosurgical procedure. Doses will be either LCM 100mg twice a day (BID) (Arm A), LEV 1000mg BID (Arm B), or no AED (Arm C). If a patient is randomized to Arm C and undergoes tumor mapping, the patient is allowed to receive one dose of AED in the operating room. If a patient is randomized to Arm A or Arm B and takes the morning dose of their AED, they do not need an intra-operative dose of AED. If a patient has a seizure during the post-operative period, AEDs will be adjusted at the discretion of the treating physician. However, if a patient has intolerable side effects, patients will be changed to a different dose of the same medicine before consideration of another AED [i.e., BID to four times a day (QID) dosing if patient experiences diplopia on LCM]. Patients with high-grade tumors (newly-diagnosed or transformed) will be treated with standard radiation and temozolomide therapy per the Stupp protocol 25,70. For these patients, an AED taper will be initiated at the first clinic visit after completion of radiation. For patients with a low-grade tumor or recurrent disease of any grade or brain metastasis, an AED taper will be initiated at the first scheduled post-operative visit, approximately 6-10 weeks after the operation. LCM will be tapered by 100mg a week one week at a time. LEV will be tapered 500-1000mg one week at a time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma, Glioma of Brain, Brain Tumor

Keywords

anti-epileptic drugs, seizure prophylaxis, levetiracetam

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Upon consent, patients will be randomized in REDCap™ to receive either LCM, LEV, or no AED. Randomization will be stratified by suspected histologic grade (LGG vs HGG vs brain metastasis) based on MRI review by the treating neurosurgeon and/or neuro-oncologist. A stratified permuted block randomization algorithm will be used assign patients to treatment arms.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lacosamide

Arm Type

Active Comparator

Arm Description

Enrolled subjects will be randomized to receive Lacosamide.

Arm Title

Levetiracetam

Arm Type

Active Comparator

Arm Description

Enrolled subjects will be randomized to receive Levetiracetam.

Arm Title

No anti-epileptic

Arm Type

No Intervention

Arm Description

Enrolled subjects will be randomized to not receive anti-epileptic drugs.

Intervention Type

Drug

Intervention Name(s)

Lacosamide

Other Intervention Name(s)

LCM, Vimpat

Intervention Description

LCM 100mg twice a day.

Intervention Type

Drug

Intervention Name(s)

Levetiracetam

Other Intervention Name(s)

LEV, Keppra

Intervention Description

LEV 1000mg twice a day.

Primary Outcome Measure Information:

Title

Percentage of Patients With an ED Visit/Hospital Readmission Within 30 Days of Craniotomy

Description

Time Frame

30 days following surgery

Secondary Outcome Measure Information:

Title

Number of Participants With an Adverse Event Within First 30 Days After Craniotomy

Description

Adverse events related to LCM, LEV, and no drug within first 30 days after craniotomy.

Time Frame

30 days following surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annick Desjardins, M.D.

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Comprehensive Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Seizure Prophylaxis in Patients With Glioma or Brain Metastasis

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