About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Arginine
- Biospecimen Collection
- Computed Tomography
- Magnetic Resonance Imaging
- Spectroscopy
- Whole-Brain Radiotherapy
Treatment groups
Sponsors and collaborators
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator