NCT04900792

A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Bryan Allen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma
• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Ferumoxytol injection	Ferumoxytol is an iron replacement product FDA approved for treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). This trial uses the FDA approved dosage (512 mg iron) for iron-deficiency anemia in CKD.
DRUG	Pharmacological ascorbate	Intravenous ascorbate
RADIATION	External beam radiation therapy	Photon based, focal radiation therapy delivered consistent with national guidelines, standard for treatment of GBM.
DRUG	Temozolomide	Temozolomide is a cytotoxic alkylating agent administered orally that penetrates well into the central nervous system. It is a standard-of-care treatment for GBM.

Timeline

• Start date: 2023-02-28
• Primary completion: 2025-05-13
• Completion: 2026-12-31
• First posted: 2021-05-25
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study