Using arginine with whole brain radiation therapy for brain metastases treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.