Study of Arginine Given Orally or Intravenously with Whole Brain Radiation Therapy to Treat Brain Metastases from Cancer

What this Trial Is About

This research evaluates different ways to give arginine, an essential amino acid, either by mouth or through an IV, to patients with cancer that has spread to the brain. The study aims to find the best dosing method and tests the safety of giving arginine alongside whole brain radiation therapy WBRT. Researchers also want to understand how arginine affects blood flow in the brain, immune responses, and metabolism during treatment. Participants are randomly assigned to one of two groups. One group receives arginine through an IV followed by WBRT about an hour later, and the other group takes arginine by mouth before WBRT. Treatment lasts for up to 10 days over 2 weeks if the disease does not worsen and side effects are manageable. During the study, patients have CT scans at screening, blood samples collected, spectroscopy tests, and MRI scans both at the start and during follow-up visits. After completing treatment, patients are monitored with follow-up visits at 1 month and then every 3 months for one year. Researchers measure arginine levels in the blood within 4 hours after dosing and track side effects during and after treatment. They also assess brain blood flow changes and study immune and metabolic effects related to the different ways arginine is given. Safety and tolerability are closely monitored throughout the trial.

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