Actively Recruiting
Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
Led by Emory University · Updated on 2025-09-17
10
Participants Needed
1
Research Sites
173 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 early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases). Arginine is an essential amino acid. Amino acids are the molecules that join together to form proteins in the body. Arginine supplementation has been shown to improve how brain metastases respond to radiation therapy. The optimal dosing of arginine for this purpose has not been determined. This study measures the level of arginine in the blood with oral and intravenous dosing at specific time intervals before and after drug administration to determine the best dosing strategy.
CONDITIONS
Official 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 allowed)
- No systemic anti-cancer therapy during whole brain radiation therapy (memantine allowed)
- Not admitted as an inpatient at treatment start
- Age 18 years or older
- Able to provide informed consent for self
You will not qualify if you...
- Unable or unwilling to receive daily arginine treatment (IV or oral) for 10 days during whole brain radiation therapy
- Receiving systemic cancer therapy during whole brain radiation therapy
- Creatinine level greater than 1.5 times the upper limit of normal
- Alanine aminotransferase (ALT) level greater than 6 times the upper limit of normal
- Planned to be treated as an inpatient
- Under 18 years of age
- Unable to provide informed consent for self
- Pregnant
- Prisoner
- Cognitive impairment or impaired decision-making capacity
AI-Screening
AI-Powered Screening
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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
CONTACT
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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