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

Conditions

• High-grade Gliomas (HGG)

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dexamethasone — DRUG
  Potent FDA-approved corticosteroid
• Azeliragon — DRUG
  orally bioavailable inhibitor of the receptor for advanced glycation endproducts (RAGE)

Study Details

The purpose of this study is to learn whether two alternatives to standard steroid treatment can safely control swelling around a brain tumor after surgery. The study will compare three approaches by placing participants in one of three study groups: standard dexamethasone (a steroid), no routine steroid treatment, and azeliragon, a study drug that may reduce brain swelling through a different pathway. Researchers want to determine whether these alternatives can control swelling while reducing some of the side effects associated with steroid use. Participants in this study will be randomly assigned to one of three study groups. Participants will undergo their planned brain tumor surgery and receive the treatment assigned to their group. Study procedures are the same as their routine care and include physical and neurological examinations, blood tests, MRI scans, review of medical records, and collection of tumor tissue removed during surgery (optional). Most study visits will occur during routine medical care. Participants will be followed for approximately 24 months after surgery.

Key Dates

First listed

Jul 9, 2026

Start date

Oct 1, 2026

Status verified

Jul 2026

Primary completion

Aug 1, 2029

Completion

Aug 1, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Dexamethasone Arm
  Standard dexamethasone (steroid) treatment
• No Intervention: No-dexamethasone Arm
  No routine dexamethasone treatment
• Experimental: Azeliragon Arm
  Azeliragon administered for the treatment of brain cancer and to evaluate its capability to control brain swelling around the time of surgery.

Primary Outcome Measure

change in peritumoral edema between the preoperative and postoperative period [ Time Frame: before the start of adjuvant chemo radiation (up to 6 weeks) ]

Central Contacts

• Akshitkumar M Mistry, MD
  502-276-5030
  [email protected]
• UofL Health Brown Cancer Center
  502-562-4370

Locations (2)

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