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Dexamethasone + Azeliragon for Brain Swelling After Glioblastoma Surgery
Study Summary
This trial tests the safety & side effects of giving dexamethasone & azeliragon to help reduce brain swelling after surgery for glioblastoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have trouble taking pills by mouth, or you have ongoing nausea or vomiting.You have a condition that affects your blood clotting or causes excessive bleeding.You are able to perform daily tasks and activities without much difficulty.You are planning to have a standard surgery to remove a brain tumor, and the doctor thinks they can remove the entire tumor.You had brain radiation less than 3 months ago, unless your doctor has confirmed that the cancer has come back or is in a different area than the radiation treatment.You have HIV.You are currently receiving treatment for another type of cancer.You have a long-term or current viral infection in your brain or spinal cord.You cannot have a brain MRI.You cannot handle taking dexamethasone.You are 18 years old or older.You have been diagnosed with a specific type of brain tumor called glioblastoma, or your brain scan shows signs of a high-grade glioma, and you are about to have surgery to confirm the diagnosis.You have received certain types of chemotherapy or targeted medications within a specific timeframe.You are currently taking a strong medication that affects the way other drugs work, and you started taking it within 14 days before the study treatment begins.You have taken certain seizure medications that affect liver enzymes within 14 days before starting the study treatment.You have an ongoing infection that needs treatment with antibiotics.Your total bilirubin level should be less than 1.5 times the upper limit of normal, unless you have Gilbert's disease.If there is a shift in the middle of the brain on the pre-surgery MRI, it must be less than 10 millimeters.If you are taking more than 3 mg of dexamethasone twice a day, the doctor expects you to be able to lower the dose to 3 mg twice a day at least 6 days before the surgery.You need to have a certain amount of a type of white blood cell called neutrophils in your blood.Your platelet count is at least 100,000 per cubic millimeter.Your AST blood test result is not more than 1.5 times the upper limit of normal.Your corrected QT interval is less than or equal to 480 milliseconds.Your alanine aminotransferase (ALT) level should be no more than 1.5 times the upper limit of normal (ULN).Your kidneys are working well, with a clearance of at least 60 mL/min.Your blood clotting levels are not more than 1.5 times the normal range.Your activated partial thromboplastin time (aPTT) test result is not more than 1.5 times the upper limit of normal.
- Group 1: Arm II (dexamethasone)
- Group 2: Arm I (azeliragon, dexamethasone)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there any risk of harm associated with the combination of azeliragon and dexamethasone?
"With the limited data available to our team at Power, we assessed arm I (azeliragon and dexamethasone) with a score of 1 on safety. This is due to its Phase 1 clinical trial status, indicating that there has been little evidence towards both efficacy and safety thus far."
Are new participants being taken into this clinical trial at the moment?
"According to the information disseminated on clinicaltrials.gov, this study is currently not enrolling any individuals. This trial was initially posted in June of 2023 and last modified in March of the same year. Although no longer recruiting participants, 729 other medical trials are actively seeking candidates at present."
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