GlioblastomaPhase 1XACT-Fe-GBM-01NCT04900792
A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma
A Phase 1 study testing Ferumoxytol injection, Pharmacological ascorbate and External beam radiation therapy in people with Glioblastoma and Glioblastoma Multiforme, run by Bryan Allen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme
- What is being tested?
- Ferumoxytol injection, Pharmacological ascorbate and External beam radiation therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness and ability to provide informed consent consistent with Good Clinical Practice (i.e., legally authorized representative will not be used / allowed for this study).
- Stated willingness to comply with all study procedures for the duration of the study
- Aged 18 years or older.
- Newly diagnosed (i.e., within 6 weeks), histologically or molecularly confirmed glioblastoma or diffuse midline glioma.
- Therapy to begin within 6 weeks of last surgery
- Able to take oral medication
Show all 12Show fewer
- ECOG performance status of 0, 1, or 2 (KPS of >50)
- Recommended to receive temozolomide and radiation therapy
- Medically fit, as determined by the prescribing oncologists, to undergo temozolomide and radiation therapy.
- Agree to use of highly effective contraception from screening until at least 90 days after the last study treatment (study participant should not discontinue contraception until discussing with their treating oncologist(s)).
- Not have significant co-morbid central nervous system disease, such as multiple sclerosis.
- Agree to Lifestyle Considerations throughout study duration
Who cannot join
- Current use of the following drugs and cannot have a drug substitution or decline the drug substitution: warfarin, flecainide, methadone, amphetamines, quinidine, and chlorpropamide. Pharmacologic ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs.
- Current use of antiretroviral drugs (e.g., nelfinavir, abacavir, emtricitabine, lamivudine, stavudine, tenofovir disoproxil fumarate, zidovudine). Pharmacologic ascorbate acid is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral drugs.
- Insulin requirement
- Requires blood glucose monitoring using finger-stick glucose checks.
- Medical requirement or indication for iron supplementation (including ferumoxytol, ferrous gluconate, ferrous fumarate, or ferrous sulfate). NOTE: Over the counter, patient-elective supplementation is acceptable.
- Inability to undergo MR imaging.
Show all 17Show fewer
- Pregnancy or lactation (note: potential participants should not engage in 'pump \& dump' strategy; lactation must be discontinued).
- Known allergic reactions to ferumoxytol.
- History of Steven's Johnson Syndrome
- History of hemochromatosis.
- Prior radiation treatment that would result in field overlap. For potential participants who have undergone nuclear medicine therapy, including PRRT, the study's radiation oncologist must approve study entry.
- G6PD (glucose-6-phosphate dehydrogenase) deficiency
- Platelet count < 100,000 /mm3 within 21 days of first treatment
- Creatinine ≥ 1.5x the institutional upper limit of normal within 21 days of the first treatment or if creatinine is elevated a creatinine clearance of < 60 mL/(min 1.73 m2)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring inpatient admission or a delay to start of therapy), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Treatment with another investigational drug within 30 days prior to study treatment day 1. Imaging trials (including investigational PET or NM tracers) as well as observational trials are acceptable.
- Clinical trials with an endpoint of treating the patient's cancer, including behavioral, nutritional and/or device human subject studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Radiation Oncology at University of Iowa
Iowa City, Iowa, 52242
About this study
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
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.
Read the 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
- Being tested
- Ferumoxytol injection, Pharmacological ascorbate, External beam radiation therapy, Temozolomide
- Keywords
- ascorbate, radiation therapy, temozolomide, ferumoxytol
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferumoxytol injectionDrug
Also called Feraheme, Ferumoxytol
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.
Pharmacological ascorbateDrug
Also called ASCOR, vitamin C, ascorbic acid
Intravenous ascorbate
External beam radiation therapyRadiation
Also called EBRT, radiotherapy, VMAT
Photon based, focal radiation therapy delivered consistent with national guidelines, standard for treatment of GBM.
TemozolomideDrug
Also called Temodar, temozolomide capsule
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (starting) | Experimental | Radiation Phase
* Ascorbate: 87.5 g administered intravenously (IV) three times each calendar week for approximately 8 weeks.
* Ferumoxytol: 512 g administered intravenously (IV) the day before radiation and then during weeks 5 to 6 of radiation therapy.
* Radiation: 61.2 Gray (given 1.8 Gray once daily, 5 days per week, for about 7 weeks) or 60 Gray (2.0 Gray once daily for 5 days per week for about 6 weeks)
* Temozolomide: 75 mg/m2, taken orally, once daily, every day, for up to 49 days or until radiation is completed (whichever comes first).
Adjuvant Phase
* Temozolomide: 150 to 200 mg/m2, taken orally, once daily, for five days out of 28 days (where 28 days is one cycle of chemotherapy) for up to six cycles
* Ascorbate: 87.5 g administered intravenously (IV) twice each calendar week of the cycle
* Ferumoxytol: 512 g administered intravenously (IV) the first day of the first cycle of chemotherapy. Receives: Drug: Ferumoxytol injection; Drug: Pharmacological ascorbate; Radiation: External beam radiation therapy; Drug: Temozolomide |
| Cohort 2 | Experimental | Radiation Phase
* Ascorbate: 87.5 g administered intravenously (IV) three times each calendar week for approximately 8 weeks.
* Ferumoxytol: 512 g administered intravenously (IV) the day before radiation, about 1 week after dose 1, during weeks 5 to 6 of radiation therapy, and then a week after that (for a total of 4 ferumoxytol infusions).
* Radiation: 61.2 Gray (given 1.8 Gray once daily, 5 days per week, for about 7 weeks) or 60 Gray (2.0 Gray once daily for 5 days per week for about 6 weeks)
* Temozolomide: 75 mg/m2, taken orally, once daily, every day, for up to 49 days or until radiation is completed (whichever comes first).
Adjuvant Phase
* Temozolomide: 150 to 200 mg/m2, taken orally, once daily, for five days out of 28 days (where 28 days is one cycle of chemotherapy) for up to six cycles
* Ascorbate: 87.5 g administered intravenously (IV) twice each calendar week of the cycle
* Ferumoxytol: 512 g administered intravenously (IV) the first day of the first cycle of Receives: Drug: Ferumoxytol injection; Drug: Pharmacological ascorbate; Radiation: External beam radiation therapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Ferumoxytol-related Dose Limiting Toxicities (DLTs)
The recommended dose will be determined by incidence of dose limiting toxicities.
Measured: From treatment day 1 through 12 weeks after completing radiation
Secondary outcomes (4)
Estimate Progression Free Survival (PFS)
Time (measured in months) to documented disease progression in MRI imaging as described by the RANO criteria.
Measured: From treatment day 1 to disease progression, up to 16 months post-treatment
Estimate Overall Survival (OS)
Time to death from any cause.
Measured: 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.
Measured: 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.
Measured: Up to 36 months post-radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start28 Feb 2023
- Primary completion13 May 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bryan Allen
- Sponsor type
- University, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Bryan Allen, University of Iowa
- Investigators
- John M. Buatti, MD, Study director, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900792
- Sponsor's protocol ID
- 202103125
- Other IDs
- 1R21CA270742
- Acronym
- XACT-Fe-GBM-01
- Status last verified
- Jun 2026
- First submitted
- 16 May 2021
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be released publicly as per participant consent and IRB approval. Individual researchers should contact the research team for data sharing.
Publications
Allen BG, Bodeker KL, Smith MC, Monga V, Sandhu S, Hohl R, Carlisle T, Brown H, Hollenbeck N, Vollstedt S, Greenlee JD, Howard MA, Mapuskar KA, Seyedin SN, Caster JM, Jones KA, Cullen JJ, Berg D, Wagner BA, Buettner GR, TenNapel MJ, Smith BJ, Spitz DR, Buatti JM. First-in-Human Phase I Clinical Trial of Pharmacologic Ascorbate Combined with Radiation and Temozolomide for Newly Diagnosed Glioblastoma. Clin Cancer Res. 2019 Nov 15;25(22):6590-6597. doi: 10.1158/1078-0432.CCR-19-0594. Epub 2019 Aug 19.
PubMed 31427282Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.
PubMed 28366679
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04900792
- Acronym / sponsor ID
- XACT-Fe-GBM-01 / 202103125
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Keywords
- ascorbate, radiation therapy, temozolomide, ferumoxytol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bryan AllenUniversity, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center, National Cancer Institute (NCI)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (starting) | Experimental | Drug: Ferumoxytol injection, Drug: Pharmacological ascorbate, Radiation: External beam radiation therapy, Drug: TemozolomideRadiation Phase * Ascorbate: 87.5 g administered intravenously (IV) three times each calendar week for approximately 8 weeks. * Ferumoxytol: 512 g administered intravenously (IV) the day before radiation and then during weeks 5 to 6 of radiation therapy. * Radiation: 61.2 Gray (given 1.8 Gray once daily, 5 days per week, for about 7 weeks) or 60 Gray (2.0 Gray once daily for 5 days per week for about 6 weeks) * Temozolomide: 75 mg/m2, taken orally, once daily, every day, for up to 49 days or until radiation is completed (whichever comes first). Adjuvant Phase * Temozolomide: 150 to 200 mg/m2, taken orally, once daily, for five days out of 28 days (where 28 days is one cycle of chemotherapy) for up to six cycles * Ascorbate: 87.5 g administered intravenously (IV) twice each calendar week of the cycle * Ferumoxytol: 512 g administered intravenously (IV) the first day of the first cycle of chemotherapy. |
| Cohort 2 | Experimental | Drug: Ferumoxytol injection, Drug: Pharmacological ascorbate, Radiation: External beam radiation therapy, Drug: TemozolomideRadiation Phase * Ascorbate: 87.5 g administered intravenously (IV) three times each calendar week for approximately 8 weeks. * Ferumoxytol: 512 g administered intravenously (IV) the day before radiation, about 1 week after dose 1, during weeks 5 to 6 of radiation therapy, and then a week after that (for a total of 4 ferumoxytol infusions). * Radiation: 61.2 Gray (given 1.8 Gray once daily, 5 days per week, for about 7 weeks) or 60 Gray (2.0 Gray once daily for 5 days per week for about 6 weeks) * Temozolomide: 75 mg/m2, taken orally, once daily, every day, for up to 49 days or until radiation is completed (whichever comes first). Adjuvant Phase * Temozolomide: 150 to 200 mg/m2, taken orally, once daily, for five days out of 28 days (where 28 days is one cycle of chemotherapy) for up to six cycles * Ascorbate: 87.5 g administered intravenously (IV) twice each calendar week of the cycle * Ferumoxytol: 512 g administered intravenously (IV) the first day of the first cycle of |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willingness and ability to provide informed consent consistent with Good Clinical Practice (i.e., legally authorized representative will not be used / allowed for this study).
- Stated willingness to comply with all study procedures for the duration of the study
- Aged 18 years or older.
- Newly diagnosed (i.e., within 6 weeks), histologically or molecularly confirmed glioblastoma or diffuse midline glioma.
- Therapy to begin within 6 weeks of last surgery
Key exclusion criteria (17 listed)
- Current use of the following drugs and cannot have a drug substitution or decline the drug substitution: warfarin, flecainide, methadone, amphetamines, quinidine, and chlorpropamide. Pharmacologic ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs.
- Current use of antiretroviral drugs (e.g., nelfinavir, abacavir, emtricitabine, lamivudine, stavudine, tenofovir disoproxil fumarate, zidovudine). Pharmacologic ascorbate acid is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral drugs.
- Insulin requirement
- Requires blood glucose monitoring using finger-stick glucose checks.
- Medical requirement or indication for iron supplementation (including ferumoxytol, ferrous gluconate, ferrous fumarate, or ferrous sulfate). NOTE: Over the counter, patient-elective supplementation is acceptable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferumoxytol injectionAlso: Feraheme, FerumoxytolFerumoxytol 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 | Cohort 1 (starting), Cohort 2 |
| Pharmacological ascorbateAlso: ASCOR, vitamin C, ascorbic acidIntravenous ascorbate | Drug | Cohort 1 (starting), Cohort 2 |
| External beam radiation therapyAlso: EBRT, radiotherapy, VMATPhoton based, focal radiation therapy delivered consistent with national guidelines, standard for treatment of GBM. | Radiation | Cohort 1 (starting), Cohort 2 |
| TemozolomideAlso: Temodar, temozolomide capsuleTemozolomide is a cytotoxic alkylating agent administered orally that penetrates well into the central nervous system. It is a standard-of-care treatment for GBM. | Drug | Cohort 1 (starting), Cohort 2 |
Primary outcome
Number of Ferumoxytol-related Dose Limiting Toxicities (DLTs)
Time frame: From treatment day 1 through 12 weeks after completing radiation
The recommended dose will be determined by incidence of dose limiting toxicities.
4 secondary outcomes
Estimate Progression Free Survival (PFS)
Time frame: From treatment day 1 to disease progression, up to 16 months post-treatment
Estimate Overall Survival (OS)
Time frame: Time (measured in months) until death from any cause, up to 26 months post-treatment
Disease Response
Time frame: 12 weeks post-radiation
Number of Participants With Treatment-Related Adverse Events
Time frame: Up to 36 months post-radiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31427282Allen BG, Bodeker KL, Smith MC, Monga V, Sandhu S, Hohl R, Carlisle T, Brown H, Hollenbeck N, Vollstedt S, Greenlee JD, Howard MA, Mapuskar KA, Seyedin SN, Caster JM, Jones KA, Cullen JJ, Berg D, Wagner BA, Buettner GR, TenNapel MJ, Smith BJ, Spitz DR, Buatti JM. First-in-Human Phase I Clinical Trial of Pharmacologic Ascorbate Combined with Radiation and Temozolomide for Newly Diagnosed Glioblastoma. Clin Cancer Res. 2019 Nov 15;25(22):6590-6597. doi: 10.1158/1078-0432.CCR-19-0594. Epub 2019 Aug 19.
- Background: PubMed 28366679Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.
- Individual participant dataSharing planned: Yes. Data will be released publicly as per participant consent and IRB approval. Individual researchers should contact the research team for data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M. Buatti, MD study director
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ferumoxytol injection, Pharmacological ascorbate and External beam radiation therapy in people with Glioblastoma and Glioblastoma Multiforme, run by Bryan Allen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Ferumoxytol-related Dose Limiting Toxicities (DLTs) (time frame: From treatment day 1 through 12 weeks after completing radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04900792, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.