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New treatment option for Metastatic Malignant Neoplasm in the Brain
Official title Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
ClinicalTrials.gov ID: NCT06328686
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.