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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of brain metastases from any primary cancer.

- Planned to undergo whole-brain radiation therapy (Hippocampal avoidant is ok) - No systemic anti-neoplastic agent concurrent with WBRT (memantine is ok) - Not inpatient at the time of treatment start.

- Age 18 or older.

- Able to consent for self.

Exclusion Criteria:

- Patient unwilling/unable to receive daily arginine treatment (IV or oral) for the 10 days of WBRT.

- Systemic therapy continuing during WBRT.

- Creatinine > 1.5 x the upper limit of normal.

- Alanine aminotransferase (ALT) > 6x the upper limit of normal.

- Patient planned to be treated as an inpatient.

- Age < 18 years.

- Adult not able to consent for self.

- Pregnant.

- Prisoners.

- Cognitively impaired/impaired decision-making capacity

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06328686
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Emory University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lisa Sudmeier, MD, PhD
Principal Investigator Affiliation	Emory University Hospital/Winship Cancer Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm

Additional Details

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.#46;) IV arginine.

V. Describe the metabolic effects of oral vs.#46; 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.

Arms & Interventions

Arms

Experimental: Arm A (IV L-arginine, WBRT)

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 CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.

Experimental: Arm B (oral L-arginine, WBRT)

Patients receive L-arginine 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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Atlanta, Georgia

Status

Address

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

Site Contact

Lisa Sudmeier, MD, PhD

[email protected]

404-712-9625

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