Using arginine with whole brain radiation therapy for brain metastases treatment
Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases
This study is testing if taking arginine, either by mouth or through an IV, can help improve the effectiveness of whole brain radiation therapy for people with brain metastases.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06328686 on ClinicalTrials.gov |
What this trial studies
This early phase I trial evaluates the safety and effectiveness of arginine, an essential amino acid, administered either orally or intravenously in conjunction with whole brain radiation therapy for patients with brain metastases. The study aims to determine the bioavailability of orally-administered arginine and assess its impact on the response of brain metastases to radiation therapy. Patients will be randomized into two arms, receiving either IV or oral arginine before radiation treatment, with follow-up assessments including blood tests and imaging studies to monitor outcomes. The study will also explore the side effects and immunological and metabolic effects of both administration routes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older diagnosed with brain metastases who are scheduled to undergo whole brain radiation therapy.
Not a fit: Patients currently receiving systemic anti-neoplastic therapy or those with significant renal or liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of radiation therapy for patients with brain metastases.
How similar studies have performed: While the combination of arginine and radiation therapy is being explored, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Pregnant * Prisoners * Cognitively impaired/impaired decision-making capacity
Where this trial is running
Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Sudmeier, MD, PhD — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Lisa Sudmeier, MD, PhD
- Email: lisa.jane.sudmeier@emory.edu
- Phone: 404-778-3473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.