Could a new drug replace steroids for brain tumor swelling?

NCT ID NCT07694089

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial compares three approaches to manage brain swelling after surgery for high-grade glioma: standard steroids (dexamethasone), no routine steroids, and a study drug called azeliragon that targets swelling through a different mechanism. The goal is to see if these alternatives can control swelling with fewer side effects. About 80 adults with newly diagnosed glioma will be randomly assigned to one of the three groups and followed for two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexamethasone and Azeliragon
What this could lead to
If successful, this could offer safer ways to manage brain swelling after tumor surgery, reducing steroid-related side effects.
What could go wrong
This is a small, early-phase trial. The alternatives may not control swelling as well as steroids, or could have unknown risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Age ≥18 years at the time of screening * Newly diagnosed supratentorial tumor with imaging characteristics consistent with high-grade glioma * Candidate for craniotomy with planned resection of more than 50% of the contrast-enhancing tumor * Midline shift ≤10 mm on preoperative imaging * Limited pre-enrollment corticosteroid exposure (≤10 mg dexamethasone total and no chronic steroid use within 30 days) * Karnofsky Performance Status ≥60 * Adequate organ function to undergo surgery and postoperative care as determined by the investigator * Ability to provide informed consent and comply with study procedures * Agreement to use effective contraception, when applicable Exclusion Criteria: * Participants meeting any of the following will be excluded: * Imaging or clinical features highly suggestive of primary CNS lymphoma or metastatic disease * Posterior fossa tumors or lesions associated with high risk of brainstem compression * Leptomeningeal or widely disseminated disease * Clinical conditions requiring immediate corticosteroid therapy * Prior exposure to high-dose corticosteroids (\>10 mg dexamethasone) or chronic steroid use within 30 days * Active systemic illness that increases surgical risk, including uncontrolled infection, coagulopathy, or severe cardiopulmonary disease * Pregnancy or breastfeeding * Known immunodeficiency or chronic infection requiring immunosuppressive therapy * Use of investigational agents within 30 days or concurrent use of immunosuppressive medications not permitted by protocol * Known hypersensitivity to azeliragon * Inability to undergo MRI due to contraindications such as incompatible implants or severe claustrophobia * Life expectancy less than 3 months as determined by the investigator * Participation in another interventional clinical trial prior to initiation of standard adjuvant therapy Vulnerable Populations: This study will not enroll children, pregnant or breastfeeding individuals, or prisoners. Individuals with impaired decision-making capacity may be enrolled only when a legally authorized representative is available to provide consent in accordance with institutional and regulatory requirements.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UofL Health Brown Cancer Center; University of Louisville Hospital

    Louisville, Kentucky, 40202, United States

  • UofL Health Jewish Hospital

    Louisville, Kentucky, 40202, United States