What this study is
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.
What's being tested
- Arginine
Intervention · DRUG
Given IV or PO
- Biospecimen Collection
Intervention · PROCEDURE
Undergo collection of blood samples
- Computed Tomography
Intervention · PROCEDURE
Undergo CT
- Magnetic Resonance Imaging
Intervention · PROCEDURE
Undergo MRI
- Spectroscopy
Intervention · PROCEDURE
Undergo spectroscopy
- Whole-Brain Radiotherapy
Intervention · RADIATION
Undergo WBRT
Study details
- Official title
- Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases
- Sponsor
- Emory University
- Conditions
- Metastatic Malignant Neoplasm in the Brain · Metastatic Malignant Solid Neoplasm
- Enrolling
- 10 people
- Starts
- 2024-09-05
- Est. completion
- 2028-12-31
- Design
- Open-label, randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openEmory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
- Lisa Sudmeier, MD, PhD · Contact404-712-9625lsudmei@emory.edu
- Agnes Harutyunyan · Contactaharuty@emory.edu
- Lisa Sudmeier, MD, PhD · Principal investigator
Recruiting
Study team
Sponsor
Emory University
Study ID STUDY00005787
Principal investigator
Lisa Sudmeier, MD, PhD
Emory University Hospital/Winship Cancer Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.