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

StatusRecruiting
PhaseEarly Phase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Dec 31, 2027
See other at-risk trials from Emory University

Record History

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  1. Primary completion pushed from Dec 31, 2026 to Dec 31, 2027 Show 5 more changesShow less
    • Study completion pushed from Dec 31, 2027 to Dec 31, 2028
    • Interventions modified
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised
  2. Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 30, 2024 to Sep 5, 2024
    • Site details revised
    v4
  4. Start date: May 31, 2024 to Aug 30, 2024v3
  5. Start date: Apr 1, 2024 to May 31, 2024v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06328686
Lead Sponsor Emory University
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm
Related terms Brain Neoplasms, Neoplasm Metastasis
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov