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Metastatic Malignant Neoplasm in the BrainSupplementsNutrition and dietCancerDrugProcedureRadiationEarly Phase 1

What this study is

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.

What's being tested

  • Arginine

    Intervention · DRUG

    Given IV or PO

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo collection of blood samples

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Spectroscopy

    Intervention · PROCEDURE

    Undergo spectroscopy

  • Whole-Brain Radiotherapy

    Intervention · RADIATION

    Undergo WBRT

Study details

Official title
Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases
Sponsor
Emory University
Conditions
Metastatic Malignant Neoplasm in the Brain · Metastatic Malignant Solid Neoplasm
Enrolling
10 people
Starts
2024-09-05
Est. completion
2028-12-31
Design
Open-label, randomized, parallel groups, Early Phase 1
Record
View on ClinicalTrials.gov ↗