What side effects are associated with this type of intervention?

Common treatments for glioblastoma include corticosteroids like dexamethasone and RAGE inhibitors like azeliragon. Dexamethasone, used to reduce inflammation, can cause side effects such as increased blood sugar, insomnia, weight gain, and a higher risk of infection. Azeliragon, aimed at decreasing cerebral edema, may have side effects including headache, dizziness, and gastrointestinal issues. Both treatments are generally well-tolerated but require monitoring for potential adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for glioblastoma include temozolomide, a standard chemotherapy drug, and bevacizumab, an anti-angiogenic agent. Dexamethasone, a corticosteroid, is commonly used to manage cerebral edema and reduce inflammation in glioblastoma patients. While azeliragon, a RAGE inhibitor, is being studied for its potential to decrease cerebral edema, it has not yet received FDA approval for this indication. Current treatments focus on managing symptoms and slowing disease progression.

What other types of research exist?

Promising novel alternatives for glioblastoma treatment in 2024 include: 1) Tumor Treating Fields (TTFields) - a non-invasive therapy using electric fields to disrupt cancer cell division. 2) Bevacizumab - an anti-VEGF antibody that reduces edema by inhibiting blood vessel growth. 3) CAR-T cell therapy - a personalized immunotherapy targeting specific tumor antigens. 4) ONC201 - a small molecule targeting dopamine receptor D2, showing potential in recurrent glioblastoma. These alternatives offer different mechanisms of action and may provide additional options for managing glioblastoma.

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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

Must not have

The patient is taking a medication that is a strong CYP3A4 inducers/ inhibitors within 14 days prior to day -6 of protocol therapy

The patient is unwilling to stop taking herbal medications prior to the start of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days post-last dose of protocol therapy

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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 below

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You are able to perform daily tasks and activities without much difficulty.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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You have an ongoing infection that needs treatment with antibiotics.

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You are currently receiving treatment for another type of cancer.

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You have trouble taking pills by mouth, or you have ongoing nausea or vomiting.

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You have a long-term or current viral infection in your brain or spinal cord.

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You have a condition that affects your blood clotting or causes excessive bleeding.

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You cannot handle taking dexamethasone.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post-last dose of protocol therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Lack of feasibility

Secondary study objectives

Azeliragon concentrations

Cytokines/chemokines

Volume of cerebral edema

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2650

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glioblastoma treatments often include corticosteroids such as dexamethasone and RAGE inhibitors like azeliragon. Dexamethasone works by reducing inflammation and lowering the immune response, which helps to manage cerebral edema (swelling) that can occur post-surgery. This is crucial for alleviating symptoms and improving patient comfort. Azeliragon, a RAGE inhibitor, blocks the RAGE pathway, which is implicated in the development of cerebral edema. By decreasing this swelling, azeliragon can potentially enhance the effectiveness of other treatments and improve overall outcomes. These mechanisms are vital for Glioblastoma patients as they help manage symptoms and improve the quality of life during treatment.