Trial Title:
Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
NCT ID:
NCT06328686
Condition:
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Brain Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Arginine
Description:
Given IV or PO
Arm group label:
Arm A (IV L-arginine, WBRT)
Arm group label:
Arm B (oral L-arginine, WBRT)
Other name:
Amino-5-guanidino-pentanoic acid
Other name:
Arg
Other name:
L-Arginine
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Arm A (IV L-arginine, WBRT)
Arm group label:
Arm B (oral L-arginine, WBRT)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Arm A (IV L-arginine, WBRT)
Arm group label:
Arm B (oral L-arginine, WBRT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm A (IV L-arginine, WBRT)
Arm group label:
Arm B (oral L-arginine, WBRT)
Other name:
Magnetic Resonance
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Spectroscopy
Description:
Undergo spectroscopy
Arm group label:
Arm A (IV L-arginine, WBRT)
Arm group label:
Arm B (oral L-arginine, WBRT)
Intervention type:
Radiation
Intervention name:
Whole-Brain Radiotherapy
Description:
Undergo WBRT
Arm group label:
Arm A (IV L-arginine, WBRT)
Arm group label:
Arm B (oral L-arginine, WBRT)
Other name:
WBRT
Other name:
whole-brain radiation therapy
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.
Detailed description:
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.) 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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Sudmeier, MD, PhD
Phone:
404-712-9625
Email:
lsudmei@emory.edu
Contact backup:
Last name:
Agnes Harutyunyan
Email:
aharuty@emory.edu
Investigator:
Last name:
Lisa Sudmeier, MD, PhD
Email:
Principal Investigator
Start date:
September 5, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06328686
