Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-26 @ 7:24 PM
Study NCT ID:
NCT04900792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2021-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma
Sponsor:
Bryan Allen
Organization:
Study Overview
Official Title:
A First-in-Human Clinical Trial of Pharmacologic Ascorbate and Ferumoxytol Combined With Concomitant Temozolomide and External Beam Radiation Therapy for Newly Diagnosed Glioblastoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XACT-Fe-GBM-01
Brief Summary:
This clinical trial evaluates adding ferumoxytol and pharamcologic ascorbate (vitamin C) to standard of care treatment of glioblastoma multiforme (a type of brain tumor) in adults. All subjects will receive ferumoxytol and pharmacologic ascorbate in addition to the standard treatment.
Detailed Description:
The initial, standard treatment for glioblastoma multiforme (GBM) involves maximum safe surgical resection followed by radiation combined with temozolomide (a chemotherapy pill you take by mouth).
Participants in this trial will:
* receive intravenous (IV) ferumoxytol the day before starting radiation, then around radiation treatments 6, 25, and 31.
* receive high doses of intravenous (IV) ascorbate three times a week during the combined radiation and chemotherapy phase.
* provide feedback about how they feel and their quality of life. This is done through short surveys as well as discussing with the study team.
Participants in this trial will:
* receive intravenous (IV) ferumoxytol the day before starting radiation, then around radiation treatments 6, 25, and 31.
* receive high doses of intravenous (IV) ascorbate three times a week during the combined radiation and chemotherapy phase.
* provide feedback about how they feel and their quality of life. This is done through short surveys as well as discussing with the study team.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21CA270742 | NIH | None | https://reporter.nih.gov/quic… | View |