RecruitingEarly Phase 1NCT06328686

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

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


Sponsor

Emory University

Enrollment

10 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria10

  • 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

Interventions

DIETARY_SUPPLEMENTArginine

Given IV or PO

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDURESpectroscopy

Undergo spectroscopy

RADIATIONWhole-Brain Radiotherapy

Undergo WBRT


Locations(1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT06328686


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