NCT06328686 · Emory University
Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
What this study is about
This early phase I trial evaluates different administration techniques (taken by mouth or given through a vein (IV)) 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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Arginine
Given IV or PO
PROCEDURE
Biospecimen Collection
Undergo collection of blood samples
PROCEDURE
Computed Tomography
Undergo CT
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Spectroscopy
Undergo spectroscopy
RADIATION
Whole-Brain Radiotherapy
Undergo WBRT
Primary outcome measures
Peak plasma L-arginine (arginine) and arginine metabolite concentration
Time frame: Within 4 hours of oral and intravenous (IV) dosing of L-arginine
By compartmental pharmacokinetic analysis, the plasma arginine levels at before administration, 10 min, 30 min, 1 hour, 2 hours, and 4 hours post administration will be used to estimate the median time to reach the peak plasma arginine and the mean value of peak. This will be done separately by two arms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of brain metastases from any primary cancer
- Planned to undergo whole-brain radiation therapy (Hippocampal avoidant is ok)
- No systemic anti-neoplastic agent concurrent with WBRT (memantine is ok)
- Not inpatient at the time of treatment start
- Age 18 or older
- Able to consent for self
Exclusion criteria
- Patient unwilling/unable to receive daily arginine treatment (IV or oral) for the 10 days of WBRT
- Systemic therapy continuing during WBRT
- Creatinine \> 1.5 x the upper limit of normal
- Alanine aminotransferase (ALT) \> 6x the upper limit of normal
- Patient planned to be treated as an inpatient
- Age \< 18 years
- Adult not able to consent for self
- Cognitively impaired/impaired decision-making capacity
Where
- Atlanta, Georgia
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 17, 2025 · Source of record for eligibility and locations