Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
Key facts
- Who runs it
- Emory University
- Where
- Atlanta, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 10 people, planned
- Started
- 5 Sept 2024
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Arginine
- Biospecimen Collection
- Computed Tomography
- Magnetic Resonance Imaging
- Spectroscopy
- Whole-Brain Radiotherapy
- Record updated
- 13 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Systemic therapy continuing during WBRT
- Creatinine > 1.5 x the upper limit of normal
- Alanine aminotransferase (ALT) > 6x the upper limit of normal
- Age < 18 years
- Patient unwilling/unable to receive daily arginine treatment (IV or oral) for the 10 days of WBRT
- Patient planned to be treated as an inpatient
- Adult not able to consent for self
- Pregnant
- Prisoners
- Cognitively impaired/impaired decision-making capacity
Where in United States
- Emory University Hospital/Winship Cancer InstituteAtlanta, United StatesContact: Lisa Sudmeier, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Arm A (IV L-arginine, WBRT)Treatment being tested
Patients receive L-arginine IV over 10-20 minutes followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.
Treatment: Arginine, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Spectroscopy, and Whole-Brain Radiotherapy
- Arm B (oral L-arginine, WBRT)Treatment being tested
Patients receive L-arginine PO followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.
Treatment: Arginine, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Spectroscopy, and Whole-Brain Radiotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases
- Record updated
- 13 October 2026