Low Dose Versus Standard Dose Dexamethasone for Reduction of Swelling in Patients with Primary or Metastatic Brain Tumors

StatusUnknown
PhasePhase 2
Started

Record status This record was last updated September 19, 2024 (before its estimated September 3, 2025 completion). Its status may not reflect the trial's current state.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Study Identification, Study Status, Contacts/Locationsv7
  3. Primary and study completion dates: Nov 15, 2024 to Sep 3, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 24 to confirmed 26
    • Site details revised
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Start date changed from estimate of Jul 15, 2022 to Apr 9, 2022v4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  2. Primary and study completion dates: Nov 15, 2023 to Nov 15, 2024
    • Start date: Dec 15, 2021 to Jul 15, 2022
    v2
  1. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial studies whether low dose dexamethasone works as well as standard dose dexamethasone to reduce brain swelling after brain surgery in patients with primary brain tumors or cancer that has spread from other places in the body to the brain (metastatic). Surgery is an important part of the treatment of brain tumors; however, it results in injury to surrounding brain tissue, leading to brain swelling. Dexamethasone is effective for controlling the swelling of the brain; however, dexamethasone can cause many unwanted side effects. To minimize the side effects of dexamethasone, the lowest dose needed to control swelling of the brain should be used. This research study is assessing the safety of using a lower than standard dose of dexamethasone after the surgery to control brain swelling.
Trial Details
NCT Number NCT05139043
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Malignant Brain Neoplasm, Metastatic Malignant Neoplasm in the Brain, Recurrent Malignant Brain Neoplasm
Related terms Brain Neoplasms
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov