RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-05
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06328686

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of brain metastases from any primary cancer
  2. * Planned to undergo whole-brain radiation therapy (Hippocampal avoidant is ok)
  3. * No systemic anti-neoplastic agent concurrent with WBRT (memantine is ok)
  4. * Not inpatient at the time of treatment start
  5. * Age 18 or older
  6. * Able to consent for self
  1. * Patient unwilling/unable to receive daily arginine treatment (IV or oral) for the 10 days of WBRT
  2. * Systemic therapy continuing during WBRT
  3. * Creatinine \> 1.5 x the upper limit of normal
  4. * Alanine aminotransferase (ALT) \> 6x the upper limit of normal
  5. * Patient planned to be treated as an inpatient
  6. * Age \< 18 years
  7. * Adult not able to consent for self
  8. * Pregnant
  9. * Prisoners
  10. * Cognitively impaired/impaired decision-making capacity

Contacts and Locations

Study Contact

Lisa Sudmeier, MD, PhD
CONTACT
404-778-3473
lisa.jane.sudmeier@emory.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Emory University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-05
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-09-05
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Malignant Solid Neoplasm