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Arginine and Whole Brain Radiation for Brain Metastases

This study is looking at how well arginine, an essential amino acid (a building block for proteins), works when given with whole brain radiation therapy for people whose cancer has spread to their brain (brain metastases). Researchers want to find the best way to give arginine – either through a vein (intravenously) or by mouth (orally) – and to see if it's safe. Arginine might help radiation therapy work better. You could be eligible if you have brain metastases from any cancer, are planning to have whole brain radiation, are at least 18 years old, and can consent for yourself. The main goal is to measure how much arginine gets into your blood after you take it. This is an early-phase study, and the current status is unclear, with a plan to enroll 10 participants.

Study design
This is an early-phase interventional study that will enroll 10 participants. Participants will be randomly assigned to receive arginine either intravenously or orally.
What's involved
You would receive arginine daily with whole brain radiation therapy for up to 10 days over two weeks. You will also have blood samples collected, CT scans, MRI scans, and spectroscopy.
Compensation
Not stated in the trial record.
Follow-up
MRI scans will be performed at follow-up, but the duration of follow-up is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06328686

Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Emory University
~10 participants
Updated 2025-09-17 on ClinicalTrials.gov
What's tested:ArginineBiospecimen CollectionComputed TomographyMagnetic Resonance ImagingSpectroscopyWhole-Brain Radiotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak plasma L-arginine (arginine) and arginine metabolite concentration
Measured over Within 4 hours of oral and intravenous (IV) dosing of L-arginine

Conditions

Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm

Explore related trials

Metastatic Malignant Neoplasm in the Brain

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Lisa Sudmeier, MD, PhD · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Lisa Sudmeier, MD, PhD
[email protected]
404-778-3473
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
Pregnant
Prisoners
Cognitively impaired/impaired decision-making capacity

What this trial measures

  • Peak plasma L-arginine (arginine) and arginine metabolite concentrationWithin 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.