Dexamethasone + Azeliragon for Brain Swelling After Glioblastoma Surgery

Recruiting in Palo Alto (17 mi)

Overseen byJana L Portnow

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests the safety and best dose of combining dexamethasone and azeliragon to manage brain swelling after surgery in glioblastoma patients. Dexamethasone reduces inflammation, and azeliragon blocks a pathway that causes swelling. Dexamethasone is commonly used to reduce brain swelling and inflammation in patients with brain tumors, but prolonged use can lead to significant complications.

Eligibility Criteria

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.

Inclusion Criteria

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.

The patient is not planning to participate in another clinical trial during the study period

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Exclusion 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 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.

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Participant Groups

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.

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.