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A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma — XACT-Fe-GBM-01  

Glioblastoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04900792
Study type Interventional
Source University of Iowa
Contact
Status Active, not recruiting
Phase Phase 1
Start date February 28, 2023
Completion date December 31, 2025
View Details
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