Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases (NCT06328686)
Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (11 items).
Location: Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
📞 Contact the Study Coordinator
Phone: (404) 778-3473
Email: lisa.jane.sudmeier@emory.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Malignant Neoplasm in the Brain
- Nivolumab and Radiation Therapy With or Without Ipilimumab in Treating Patients With Brain Metastases From Non-small Cell Lung Cancer — Houston, Texas
- Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases — Phoenix, Arizona
- Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients With Brain Metastases — Columbus, Ohio
- Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery — Sewell, New Jersey
- Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases — Houston, Texas
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.