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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06328686
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Arginine — DIETARY_SUPPLEMENT
    Given IV or PO
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Spectroscopy — PROCEDURE
    Undergo spectroscopy
  • Whole-Brain Radiotherapy — RADIATION
    Undergo WBRT

Study Details

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.

Key Dates

Start date
Sep 5, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Lisa Sudmeier, MD, PhD
[email protected]
404-712-9625
Agnes Harutyunyan
[email protected]
Lisa Sudmeier, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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