RecruitingEarly Phase 1NCT06328686

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

Sponsor

Emory University

Enrollment

10 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Malignant Solid Neoplasm Metastatic Malignant Neoplasm in the Brain

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving patients the amino acid arginine alongside whole-brain radiation therapy (WBRT) helps protect brain function in people with brain metastases (cancer that has spread to the brain from elsewhere in the body). Whole-brain radiation is effective but can cause memory and cognitive side effects; arginine may help protect the brain during treatment. **You may be eligible if...** - You are 18 or older - You have brain metastases from any type of cancer - You are scheduled to receive whole-brain radiation therapy - You are able to consent for yourself - You are not currently hospitalized as an inpatient at treatment start **You may NOT be eligible if...** - You are unwilling or unable to take daily arginine (by IV or by mouth) for the 10 days of radiation - You are receiving other cancer treatments at the same time as the radiation - You have significant kidney or liver problems - You are pregnant - You are currently incarcerated - You have cognitive impairment that prevents self-consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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