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Dexamethasone and Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma

NCT05773664 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

Summary

This phase I trial tests the safety, side effects, and best dose of dexamethasone when given with azeliragon in managing cerebral edema after surgery (post-resection) in patients with glioblastoma. Cerebral edema is a pathological increase in the water mass contained within the brain interstitial space. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Azeliragon is an oral RAGE inhibitor. Blocking the RAGE pathway at the time of surgery (peri-operatively) may decrease cerebral edema. Giving dexamethasone with azeliragon may help control post-operative cerebral edema in decreasing doses of concurrently administered dexamethasone.

Conditions

Interventions

DRUG

Azeliragon

Given PO

PROCEDURE

Biospecimen Collection

Undergo collection of cavity fluid and blood samples

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Dexamethasone

Given PO or IV

PROCEDURE

Magnetic Resonance Imaging of the Brain with and without Contrast

Undergo MRI with or without contrast

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Jana L Portnow · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2024-11-29
Completion
2024-11-29
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05773664 on ClinicalTrials.gov