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

Description

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.

Conditions

Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm

Study Overview

Study Details

Study overview

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.

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

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

Condition
Metastatic Malignant Neoplasm in the Brain
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Lisa Sudmeier, MD, PhD, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

Study Record Dates

2026-12-31