Recruiting
Early Phase 1

Arginine & Whole Brain Radiation Therapy

Sponsor:

Emory University

Code:

NCT06328686

Conditions

Metastatic Malignant Neoplasm in the Brain

Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arginine

Biospecimen Collection

Computed Tomography

Magnetic Resonance Imaging

Spectroscopy

Study Details

Brief 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.

Conditions

Metastatic Malignant Neoplasm in the Brain

Metastatic Malignant Solid Neoplasm

Study ID

NCT06328686

Start date

Sep 5, 2024

Status verified date

Sep, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (IV L-arginine, WBRT)

Patients receive L-arginine IV over 10-20 minutes followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.

experimental: Arm B (oral L-arginine, WBRT)

Patients receive L-arginine PO followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.

Interventions

Arginine

Given IV or PO

Biospecimen Collection

Undergo collection of blood samples

Computed Tomography

Undergo CT

Magnetic Resonance Imaging

Undergo MRI

Spectroscopy

Undergo spectroscopy

Whole-Brain Radiotherapy

Undergo WBRT

Primary outcome measure

  • Peak plasma L-arginine (arginine) and arginine metabolite concentration [ Time Frame: Within 4 hours of oral and intravenous (IV) dosing of L-arginine ]

Central Contacts and Locations

Central contacts

Lisa Sudmeier, MD, PhD

404-778-3473lisa.jane.sudmeier@emory.edu

Locations

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Lisa Sudmeier, MD, PhD

404-712-9625lsudmei@emory.edu

Agnes Harutyunyan

aharuty@emory.edu

Principal Investigator:

Lisa Sudmeier, MD, PhD

More Information

Sponsor

Emory University

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-09-17.