Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773664
Status:
WITHDRAWN
Last Update Posted:
2024-04-25
First Post:
2023-01-30
Brief Title:
Dexamethasone and Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase I De-Escalation Study of Dexamethasone with Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 bodys 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
Detailed Description:
PRIMARY OBJECTIVES
I Determine the lowest dose of dexamethasone that needs to be co-administered with azeliragon for treatment of post-resection cerebral edema in patients with glioblastoma
II Assess the safety of administering azeliragon peri-operatively to patients with glioblastoma
SECONDARY OBJECTIVES
I Describe post-operative changes in levels of cytokines and chemokines in brain interstitium and peripheral blood in study participants
II Quantitatively assess changes in the volume of cerebral edema post-operatively in study participants
III Determine brain concentrations of azeliragon in resected tumor tissue from Arm 1 participants
EXPLORATORY OBJECTIVES
I Describe post-operative changes in levels of RAGE ligands in brain interstitium peripheral blood and resection cavity fluid when possible to obtain in study participants
II Describe changes in levels of cytokines chemokines and immune cell populations in resection cavity fluid when possible to obtain
III Describe differences in levels of cytokines chemokines and RAGE ligands between patients in Arm 1 and Arm 2
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive azeliragon orally PO and dexamethasone PO or intravenously IV throughout the study Patients also undergo collection of cavity fluid and blood samples computed tomography CT scan and brain magnetic resonance imaging MRI with or without contrast throughout the study
ARM II Patients receive dexamethasone PO or IV throughout the study Patients also undergo collection of cavity fluid and blood samples CT scan and brain MRI with or without contrast throughout the study
I Determine the lowest dose of dexamethasone that needs to be co-administered with azeliragon for treatment of post-resection cerebral edema in patients with glioblastoma
II Assess the safety of administering azeliragon peri-operatively to patients with glioblastoma
SECONDARY OBJECTIVES
I Describe post-operative changes in levels of cytokines and chemokines in brain interstitium and peripheral blood in study participants
II Quantitatively assess changes in the volume of cerebral edema post-operatively in study participants
III Determine brain concentrations of azeliragon in resected tumor tissue from Arm 1 participants
EXPLORATORY OBJECTIVES
I Describe post-operative changes in levels of RAGE ligands in brain interstitium peripheral blood and resection cavity fluid when possible to obtain in study participants
II Describe changes in levels of cytokines chemokines and immune cell populations in resection cavity fluid when possible to obtain
III Describe differences in levels of cytokines chemokines and RAGE ligands between patients in Arm 1 and Arm 2
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive azeliragon orally PO and dexamethasone PO or intravenously IV throughout the study Patients also undergo collection of cavity fluid and blood samples computed tomography CT scan and brain magnetic resonance imaging MRI with or without contrast throughout the study
ARM II Patients receive dexamethasone PO or IV throughout the study Patients also undergo collection of cavity fluid and blood samples CT scan and brain MRI with or without contrast throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-00007 | REGISTRY | None | None |
| 22367 | OTHER | None | None |
| P30CA033572 | NIH | None | None |
| U19CA264512 | NIH | City of Hope Medical Center | httpsreporternihgovquickSearchU19CA264512 |