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Dexamethasone + Azeliragon for Brain Swelling After Glioblastoma Surgery
Phase 1
Waitlist Available
Led By Jana L Portnow
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status of >= 60%
Histologically confirmed glioblastoma or radiographic findings consistent with a high grade glioma in patients undergoing surgery for initial diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post-last dose of protocol therapy
Awards & highlights
Study Summary
This trial tests the safety & side effects of giving dexamethasone & azeliragon to help reduce brain swelling after surgery for glioblastoma.
Who is the study for?
Adults with confirmed glioblastoma or signs of high-grade glioma who are undergoing surgery can join. They must have a good performance status, not be in another trial, and have recovered from previous treatments. Women of childbearing age need a negative pregnancy test and agree to birth control. Participants should not have severe illnesses, bleeding disorders, HIV, other cancers, or be unable to take oral meds or undergo MRIs.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dose of dexamethasone combined with azeliragon for reducing brain swelling after tumor removal surgery in glioblastoma patients. Dexamethasone is an anti-inflammatory steroid; azeliragon blocks RAGE pathways potentially decreasing cerebral edema.See study design
What are the potential side effects?
Possible side effects include immune system suppression leading to increased infection risk, blood sugar increases (common with steroids like dexamethasone), potential digestive issues due to oral medication intake (azeliragon), mood swings or sleep disturbances from steroids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are able to perform daily tasks and activities without much difficulty.
Select...
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.
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You are planning to have a standard surgery to remove a brain tumor, and the doctor thinks they can remove the entire tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post-last dose of protocol therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-last dose of protocol therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Lack of feasibility
Secondary outcome measures
Azeliragon concentrations
Cytokines/chemokines
Volume of cerebral edema
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (azeliragon, dexamethasone)Experimental Treatment5 Interventions
Patients receive azeliragon PO and dexamethasone PO or IV throughout the study. Patients also undergo collection of cavity fluid and blood samples, CT scan, and brain MRI with or without contrast throughout the study.
Group II: Arm II (dexamethasone)Active Control4 Interventions
Patients receive dexamethasone PO or IV throughout the study. Patients also undergo collection of cavity fluid and blood samples, CT scan, and brain MRI with or without contrast throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,595 Total Patients Enrolled
12 Trials studying Glioblastoma
335 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,343 Total Patients Enrolled
324 Trials studying Glioblastoma
23,151 Patients Enrolled for Glioblastoma
Jana L PortnowPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
117 Total Patients Enrolled
2 Trials studying Glioblastoma
54 Patients Enrolled for Glioblastoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (dexamethasone)
- Group 2: Arm I (azeliragon, dexamethasone)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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