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Back|NCT06328686Recruiting
Official Title

Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases

Phase
Early Phase 1
Sponsor
Emory University
Enrollment
10
Timeline
Sep 2024 → Dec 2027
About This Study

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

Inclusion Criteria

  • 1Diagnosis of brain metastases from any primary cancer
  • 2Planned to undergo whole-brain radiation therapy (Hippocampal avoidant is ok)
  • 3No systemic anti-neoplastic agent concurrent with WBRT (memantine is ok)
  • 4Not inpatient at the time of treatment start
  • 5Age 18 or older
  • 6Able to consent for self

Exclusion Criteria

  • 1Patient unwilling/unable to receive daily arginine treatment (IV or oral) for the 10 days of WBRT
  • 2Systemic therapy continuing during WBRT
  • 3Creatinine \> 1.5 x the upper limit of normal
  • 4Alanine aminotransferase (ALT) \> 6x the upper limit of normal
  • 5Patient planned to be treated as an inpatient
  • 6Age \< 18 years
  • 7Adult not able to consent for self
  • 8Pregnant
  • 9Prisoners
  • 10Cognitively impaired/impaired decision-making capacity

Locations

1 site participating in this study

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Lisa Sudmeier, MD, PhD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →