NCT06328686

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Determine the bioavailability of orally-administered arginine (L-arginine). SECONDARY OBJECTIVES: I. Test the safety of daily arginine administration with standard-fractionation whole brain radiation therapy (WBRT). II. Determine the side effect profile of oral and intravenous (IV) L-arginine. III. Quantify frontal cortex blood volume/flow changes following L-arginine (L-arg) administration. IV. Describe immunological effects of oral versus (vs.) IV arginine. V. Describe the metabolic effects of oral vs. IV arginine. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: 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 computed tomography (CT) at screening, undergo collection of blood samples and spectroscopy on study, and undergo magnetic resonance imaging (MRI) at screening and follow up. ARM B: Patients receive L-arginine orally (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. After completion of study treatment, patients are followed up at 1 month and then quarterly for 1 year.

Conditions

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

Interventions

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

Timeline

• Start date: 2024-09-05
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-03-25
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study