Actively Recruiting
Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases
Led by Emory University · Updated on 2025-09-17
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates different ways to give arginine, an essential amino acid, either by mouth or through an IV, to patients with cancer that has spread to the brain. The study aims to find the best dosing method and tests the safety of giving arginine alongside whole brain radiation therapy (WBRT). Researchers also want to understand how arginine affects blood flow in the brain, immune responses, and metabolism during treatment. Participants are randomly assigned to one of two groups. One group receives arginine through an IV followed by WBRT about an hour later, and the other group takes arginine by mouth before WBRT. Treatment lasts for up to 10 days over 2 weeks if the disease does not worsen and side effects are manageable. During the study, patients have CT scans at screening, blood samples collected, spectroscopy tests, and MRI scans both at the start and during follow-up visits. After completing treatment, patients are monitored with follow-up visits at 1 month and then every 3 months for one year. Researchers measure arginine levels in the blood within 4 hours after dosing and track side effects during and after treatment. They also assess brain blood flow changes and study immune and metabolic effects related to the different ways arginine is given. Safety and tolerability are closely monitored throughout the trial.
CONDITIONS
Brief Title
Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of brain metastases from any primary cancer
- Planned to undergo whole-brain radiation therapy (hippocampal avoidant is acceptable)
- No systemic anti-cancer treatment during whole-brain radiation therapy (memantine is allowed)
- Not hospitalized as an inpatient at treatment start
- Age 18 years or older
- Able to give informed consent for oneself
You will not qualify if you...
- Unwilling or unable to receive daily arginine treatment (IV or oral) for the 10 days of radiation therapy
- Receiving systemic therapy during whole-brain radiation therapy
- Creatinine level above 1.5 times the upper normal limit
- Alanine aminotransferase (ALT) above 6 times the upper normal limit
- Planned to be treated as an inpatient
- Under 18 years of age
- Unable to give informed consent for oneself
- Pregnant
- Prisoner
- Cognitively impaired or impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
. Participants undergo computed tomography (CT) and magnetic resonance imaging (MRI) at screening.
Duration - Up to 2 weeks
Participants receive L-arginine either intravenously or orally followed approximately 1 hour later by whole brain radiation therapy (WBRT). Treatment occurs for up to 10 days over 2 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo blood sample collection and spectroscopy during this period.
Daily visits for up to 10 days of treatment over 2 weeks
Duration - 1 year
After completing treatment, participants are followed up to monitor safety and effects of treatment including MRI assessments.
Visits at 1 month post-treatment and then quarterly for 1 year
Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
L
Lisa Sudmeier, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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