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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Arginine
  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Spectroscopy
  • Whole-Brain Radiotherapy

Treatment groups

10 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator