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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
Intravenous ascorbate
Photon based, focal radiation therapy delivered consistent with national guidelines, standard for treatment of GBM.
Department of Radiation Oncology at University of Iowa
Iowa City, Iowa, United States
Number of Ferumoxytol-related Dose Limiting Toxicities (DLTs)
The recommended dose will be determined by incidence of dose limiting toxicities.
Time frame: From treatment day 1 through 12 weeks after completing radiation
Estimate Progression Free Survival (PFS)
Time (measured in months) to documented disease progression in MRI imaging as described by the RANO criteria.
Time frame: From treatment day 1 to disease progression, up to 16 months post-treatment
Estimate Overall Survival (OS)
Time to death from any cause.
Time frame: Time (measured in months) until death from any cause, up to 26 months post-treatment
Disease Response
Disease response and tumor measurements over time were assessed using Response Assessment in Neuro-Oncology (RANO) criteria in conjunction with the Neurologic Assessment in Neuro-Oncology (NANO) beginning 12 weeks after completion of radiation therapy, using radiation simulation MRI/CT as baseline. RANO disease response categories included complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). Tumor measurements obtained during radiographic assessment were incorporated into the overall RANO response evaluation.
Time frame: 12 weeks post-radiation
Number of Participants With Treatment-Related Adverse Events
Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (v5). Treatment-related adverse events were categorized by toxicity type, including liver function, hematologic, and non-hematologic events. Participants were counted once per toxicity category if they experienced at least one treatment-related adverse event within that category during the study period.
Time frame: Up to 36 months post-radiation
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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.