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Steroid Alternatives for Brain Tumor Swelling After Surgery

This study is looking for people with newly diagnosed high-grade gliomas (a type of brain tumor) to compare different ways to manage brain swelling after surgery. Researchers are testing if avoiding steroids completely or using azeliragon (a drug that may reduce swelling differently) can be as safe and effective as standard dexamethasone (a common steroid). The main goal is to see how much the swelling around the tumor changes between before surgery and up to 6 weeks after, before other treatments start. You can join if you are at least 18 years old, have a specific type of brain tumor, and are planning surgery to remove most of it. The study's current status is unclear.

Study design
This is a randomized Phase II study with 80 planned participants. You would be randomly assigned to one of three groups: standard dexamethasone, no routine steroid treatment, or azeliragon.
What's involved
Participants will undergo their planned brain tumor surgery and receive the treatment assigned to their group.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured up to 6 weeks after surgery, before the start of adjuvant chemo radiation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07694089

Steroid Avoidance, Dexamethasone, and RAGE Inhibition for Perioperative Cerebral Edema Management in High-Grade Gliomas

Not Yet Recruiting
PHASE2Ages 19+InterventionalSupportive care
Akshitkumar MIstry
~80 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:DexamethasoneAzeliragon

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
change in peritumoral edema between the preoperative and postoperative period
Measured over before the start of adjuvant chemo radiation (up to 6 weeks)

Conditions

High-grade Gliomas (HGG)

Explore related trials

Malignant Glioma

Where it's being run

2 sites across 1 states
Kentucky2

Study leadership

  • Akshitkumar M Mistry, MD · PRINCIPAL_INVESTIGATOR · UofL Health - Brown Cancer Center

Who to contact

Akshitkumar M Mistry, MD
[email protected]
502-276-5030
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • change in peritumoral edema between the preoperative and postoperative periodbefore the start of adjuvant chemo radiation (up to 6 weeks)

    The primary outcome is the change in peritumoral edema between the preoperative and postoperative period. Specifically, it is the ratio of postoperative to preoperative peritumoral edema volume, adjusted for extent of enhancing tumor removed. This outcome is derived from MRI-based volumetric assessment and reflects the effectiveness of each perioperative strategy in controlling cerebral edema while accounting for surgical factors