Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases

Study Purpose

This is a randomized trial for patients with brain metastases in the primary motor cortex who have not had seizures to receive either the prophylactic anti-seizure medication levetiracetam (also known by its trade name Keppra) or proceed with standard of care management, which does not currently include prophylactic levetiracetam. Patients who enroll to this trial will be randomized to receive prophylactic levetiracetam or not receive prophylactic levetiracetam.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type 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.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participants must have a biopsy proven solid malignancy with at least one intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis located in the primary motor cortex measuring 0.5 cm or larger in maximal unidimensional size. 2. Age of at least 18 years. 3. Karnofsky performance status of at least 60. 4. Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI. 5. Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF/HCC approved eConsent medium.

Exclusion Criteria:

1. Participants with prior seizures as this is a study for seizure naïve patients. 2. Participants with an allergy to levetiracetam as levetiracetam is the prophylactic anti-seizure medication under study. 3. Participants concurrently taking (i.e. at enrollment) an ASM for non-seizure indications at clinically relevant doses (gabapentin 1800 mg/day or higher, pregabalin 300 mg/ day or higher, lamotrigine 150 mg/ day or higher, valproic acid 1000 mg/ day or higher, topiramate 200 mg/ day or higher, carbamazepine 200 mg/ day or higher, oxcarbazepine 300 mg/ day or higher, primidone 100 mg/day or higher) because use of these medications could bias the study toward the null. 4. Participants who cannot tolerate a magnetic resonance imaging (MRI) study of the brain, which is required to determine the presence of and follow the course of brain metastases under study. 5. Participants who cannot receive gadolinium as MRI of the brain with contrast is required. 6. Participants with end stage renal disease due to risk of nephrogenic systemic fibrosis in this patient population after exposure to gadolinium-based contrast agents. 7. Participants with widespread, definitive leptomeningeal disease given that leptomeningeal disease and brain metastases are different entities. 8. Pregnant women are excluded from this study because levetiracetam crosses the placenta. In addition, the potential deleterious effects of gadolinium on the developing fetus are not completely known. 9. Women who are breastfeeding are excluded from this study because levetiracetam enters breast milk. In addition, the potential deleterious effects of gadolinium in breast milk remain unknown

Trial Details

Trial ID: 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.	NCT07130786
Phase 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 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ayal A. Aizer, MD
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ayal A Aizer, MD, MHS
Principal Investigator Affiliation	Dana-Farber/Brigham and Women's Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Seizures, Primary Motor Cortex, Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Brain Metastases, Adult, Brain Metastases From Extra-cranial Solid Tumors

Additional Details

Brain metastases (BrM) impact 10%-40% of patients with solid malignancies and are associated with significant clinical sequelae, including development of seizures. The development of seizures has the potential for significant detriment on patient quality of life. The goal of this study is to evaluate the role of levetiracetam as primary prophylaxis in seizure-naïve patients with metastases in primary motor cortex, an area at high risk of seizures. Patients will be randomized to receive levetiracetam/ASM or to receive no ASM therapy.

Arms & Interventions

Arms

Experimental: Prophylactic Levetiracetam

Levetiracetam Anti-Seizure Medication

No Intervention: No Prophylactic Levetiracetam

No Anti-Seizure Medication

Interventions

Drug: - Levetiracetam (Keppra)

Patients will be randomized to receive levetiracetam/ASM or to receive no ASM therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brigham and Women's Hospital, Boston 4930956, Massachusetts 6254926

Status

Address

Brigham and Women's Hospital

Boston 4930956, Massachusetts 6254926, 02115

Site Contact

Ayal A Aizer, MD, MHS

[email protected]

(617) 732-7560

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