protocolSection identificationModule nctId: NCT06328686, orgStudyIdInfo id: STUDY00005787, secondaryIdInfos id: NCI-2023-10895, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00005787, type: OTHER, domain: Emory University Hospital/Winship Cancer Institute, secondaryIdInfos id: WINSHIP5883-23, type: OTHER, domain: Emory University Hospital/Winship Cancer Institute, secondaryIdInfos id: P30CA138292, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA138292, briefTitle: Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: 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., conditionsModule conditions: Metastatic Malignant Neoplasm in the Brain, conditions: Metastatic Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Arginine, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Magnetic Resonance Imaging, interventions name: Spectroscopy, interventions name: Whole-Brain Radiotherapy, outcomesModule primaryOutcomes measure: Peak plasma L-arginine (arginine) and arginine metabolite concentration, secondaryOutcomes measure: Incidence of adverse events associated with delivering L-arginine with standard fractionation whole brain radiation therapy, secondaryOutcomes measure: Side effect profile of oral and IV arginine, secondaryOutcomes measure: Frontal cortex blood volume/flow changes with L-arginine administration, secondaryOutcomes measure: Describe The Immunological Effects of Oral versus IV Arginine, secondaryOutcomes measure: Describe The Metabolic Effects of Oral versus IV Arginine, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory University Hospital/Winship Cancer Institute, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Lisa Sudmeier, MD, PhD, role: CONTACT, phone: 404-712-9625, email: lsudmei@emory.edu, contacts name: Agnes Harutyunyan, role: CONTACT, email: aharuty@emory.edu, contacts name: Lisa Sudmeier, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False