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Brief Title: A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma
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
Study ID: NCT04900792
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Radiation Oncology at University of Iowa, Iowa City, Iowa, United States
Name: John M. Buatti, MD
Affiliation: University of Iowa
Role: STUDY_DIRECTOR