Trial Outcomes & Findings for A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma (NCT NCT04900792)

NCT ID: NCT04900792

Last Updated: 2026-07-20

Results Overview

The recommended dose will be determined by incidence of dose limiting toxicities.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

From treatment day 1 through 12 weeks after completing radiation

Results posted on

2026-07-20

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV the day prior to radiation initiation and again during weeks 5-6 of radiation therapy; external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.	Cohort 2 Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV administered the day prior to radiation initiation, approximately 1 week later, during weeks 5-6 of radiation therapy, and approximately 1 week thereafter (4 total infusions); external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.
Overall Study STARTED	7	9
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV the day prior to radiation initiation and again during weeks 5-6 of radiation therapy; external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.	Cohort 2 Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV administered the day prior to radiation initiation, approximately 1 week later, during weeks 5-6 of radiation therapy, and approximately 1 week thereafter (4 total infusions); external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.
Overall Study Did not meet compliance	1	1
Overall Study Physician Decision	0	1
Overall Study Travel and time commitment restraints	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From treatment day 1 through 12 weeks after completing radiation

Population: Participants who received at least one dose of pharmacological ascorbate in combination with ferumoxytol, radiation therapy, and temozolomide were included in the analysis. Six participants in Cohort 1 and six participants in Cohort 2 were evaluable for adverse event reporting. One participant in Cohort 1 discontinued treatment following a Grade 3 alanine aminotransferase increase after the first ferumoxytol infusion but was included in the adverse event analysis population.

The recommended dose will be determined by incidence of dose limiting toxicities.

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV the day prior to radiation initiation and again during weeks 5-6 of radiation therapy; external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.	Cohort 2 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV administered the day prior to radiation initiation, approximately 1 week later, during weeks 5-6 of radiation therapy, and approximately 1 week thereafter (4 total infusions); external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.
Number of Ferumoxytol-related Dose Limiting Toxicities (DLTs)	2 Dose Limiting Toxicities	0 Dose Limiting Toxicities

SECONDARY outcome

Timeframe: From treatment day 1 to disease progression, up to 16 months post-treatment

Population: Participants who completed study treatment in each cohort

Time (measured in months) to documented disease progression in MRI imaging as described by the RANO criteria.

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV the day prior to radiation initiation and again during weeks 5-6 of radiation therapy; external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.	Cohort 2 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV administered the day prior to radiation initiation, approximately 1 week later, during weeks 5-6 of radiation therapy, and approximately 1 week thereafter (4 total infusions); external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.
Estimate Progression Free Survival (PFS)	8 months Interval 4.0 to 12.0	6 months Interval 4.0 to 16.0

SECONDARY outcome

Timeframe: Time (measured in months) until death from any cause, up to 26 months post-treatment

Population: Study participants who completed treatment in each cohort

Time to death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV the day prior to radiation initiation and again during weeks 5-6 of radiation therapy; external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.	Cohort 2 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV administered the day prior to radiation initiation, approximately 1 week later, during weeks 5-6 of radiation therapy, and approximately 1 week thereafter (4 total infusions); external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.
Estimate Overall Survival (OS)	12 Months Interval 9.0 to 26.0	13 Months Interval 7.0 to 19.0

SECONDARY outcome

Timeframe: 12 weeks post-radiation

Population: Analysis included all participants with at least one post-baseline MRI evaluable by RANO criteria. Overall Response Rate was defined as CR or PR. SD was not included in ORR and was considered non-response.1 participant in cohort 1 experienced a dose limiting toxicity prior to beginning treatment and was not included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=5 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV the day prior to radiation initiation and again during weeks 5-6 of radiation therapy; external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.	Cohort 2 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV administered the day prior to radiation initiation, approximately 1 week later, during weeks 5-6 of radiation therapy, and approximately 1 week thereafter (4 total infusions); external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.
Disease Response Progressive Disease (PD)	1 Participants	1 Participants
Disease Response Complete Response (CR)	0 Participants	0 Participants
Disease Response Stable Disease (SD)	4 Participants	5 Participants
Disease Response Partial Response (PR)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 36 months post-radiation

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV the day prior to radiation initiation and again during weeks 5-6 of radiation therapy; external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.	Cohort 2 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV administered the day prior to radiation initiation, approximately 1 week later, during weeks 5-6 of radiation therapy, and approximately 1 week thereafter (4 total infusions); external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.
Number of Participants With Treatment-Related Adverse Events Liver function	5 participants	6 participants
Number of Participants With Treatment-Related Adverse Events Hematologic	5 participants	6 participants
Number of Participants With Treatment-Related Adverse Events Non-Hematologic	5 participants	6 participants

Adverse Events

Cohort 1

Serious events: 1 serious events

Other events: 6 other events

Deaths: 5 deaths

Cohort 2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=6 participants at risk Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV the day prior to radiation initiation and again during weeks 5-6 of radiation therapy; external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.	Cohort 2 n=6 participants at risk Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV administered the day prior to radiation initiation, approximately 1 week later, during weeks 5-6 of radiation therapy, and approximately 1 week thereafter (4 total infusions); external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • Adverse event data were collected from treatment initiation through 36 months post-radiation.	0.00% 0/6 • Adverse event data were collected from treatment initiation through 36 months post-radiation.
Nervous system disorders Seizure	0.00% 0/6 • Adverse event data were collected from treatment initiation through 36 months post-radiation.	16.7% 1/6 • Number of events 1 • Adverse event data were collected from treatment initiation through 36 months post-radiation.

Other adverse events

Additional Information

Bryan Allen, MBA, MD, PhD

University of Iowa

Phone: 319-356-3693

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV the day prior to radiation initiation and again during weeks 5-6 of radiation therapy; external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.	Cohort 2 n=6 Participants Participants will receive concurrent pharmacological ascorbate, ferumoxytol, radiation therapy, and temozolomide during the radiation phase, followed by adjuvant temozolomide with pharmacological ascorbate and ferumoxytol. During the radiation phase, participants will receive intravenous (IV) ascorbate 87.5 g three times weekly for approximately 8 weeks; ferumoxytol 512 mg IV administered the day prior to radiation initiation, approximately 1 week later, during weeks 5-6 of radiation therapy, and approximately 1 week thereafter (4 total infusions); external beam focal photon radiation therapy delivered as either 61.2 Gy in 1.8 Gy daily fractions or 60 Gy in 2.0 Gy daily fractions, 5 days per week for approximately 6-7 weeks; and oral temozolomide 75 mg/m2 daily for up to 49 days or until completion of radiation therapy. During the adjuvant phase, participants will receive oral temozolomide 150-200 mg/m2 once daily on Days 1-5 of each 28-day cycle for up to 6 cycles; IV ascorbate 87.5 g twice weekly during each cycle; and ferumoxytol 512 mg IV on Day 1 of Cycle 1. Temozolomide is standard-of-care therapy for glioblastoma multiforme (GBM). Ferumoxytol is FDA approved for treatment of iron deficiency anemia in adults with chronic kidney disease and will be administered at the approved dose.	Total n=12 Participants Total of all reporting groups
Sex: Female, Male Male	5 Participants n=20 Participants	4 Participants n=20 Participants	9 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=20 Participants	5 Participants n=20 Participants	10 Participants n=40 Participants
Age, Categorical >=65 years	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Age, Continuous	59 years n=20 Participants	60 years n=20 Participants	59 years n=40 Participants
Sex: Female, Male Female	1 Participants n=20 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=20 Participants	6 Participants n=20 Participants	12 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) White	6 Participants n=20 Participants	6 Participants n=20 Participants	12 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Region of Enrollment United States	6 participants n=20 Participants	6 participants n=20 Participants	12 participants n=40 Participants