Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
NCT ID: NCT06328686
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
10 participants
INTERVENTIONAL
2024-09-05
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Arginine
Given IV or PO
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Spectroscopy
Undergo spectroscopy
Whole-Brain Radiotherapy
Undergo WBRT
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.
Arginine
Given IV or PO
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Spectroscopy
Undergo spectroscopy
Whole-Brain Radiotherapy
Undergo WBRT
Interventions
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Arginine
Given IV or PO
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Spectroscopy
Undergo spectroscopy
Whole-Brain Radiotherapy
Undergo WBRT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
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Lisa Sudmeier
Principal Investigator
Principal Investigators
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Lisa Sudmeier, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2023-10895
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00005787
Identifier Type: OTHER
Identifier Source: secondary_id
WINSHIP5883-23
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00005787
Identifier Type: -
Identifier Source: org_study_id
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