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

NCT04900792 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-12-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Holden Comprehensive Cancer Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Bryan Allen

    lead OTHER

Principal Investigators

  • John M. Buatti, MD · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2025-05-13
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT04900792 on ClinicalTrials.gov