Steroid Avoidance, Dexamethasone, and RAGE Inhibition for Perioperative Cerebral Edema Management… (NCT07694089) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Steroid Avoidance, Dexamethasone, and RAGE Inhibition for Perioperative Cerebral Edema Management in High-Grade Gliomas
United States80 participantsStarted 2026-10-01
Plain-language summary
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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in peritumoral edema between the preoperative and postoperative period
Timeframe: before the start of adjuvant chemo radiation (up to 6 weeks)