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Ferumoxytol + Vitamin C for Glioblastoma (XACT-Fe-GBM-01 Trial)

Phase 1

Waitlist Available

Research Sponsored by Bryan Allen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older

Not have significant co-morbid central nervous system disease, such as multiple sclerosis

Must not have

Prior radiation treatment that would result in field overlap

G6PD deficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months post-radiation

Awards & highlights

No Placebo-Only Group

Summary

This trial tests adding ferumoxytol & vitamin C to standard brain tumor treatment to see if it helps adults.

Who is the study for?

Adults over 18 with newly diagnosed glioblastoma or diffuse midline glioma, able to start treatment within 6 weeks of surgery and take oral medication. Participants must be medically fit for standard therapy, not pregnant or breastfeeding, without significant other CNS diseases or conditions like hemochromatosis, G6PD deficiency, uncontrolled illnesses, certain drug dependencies (e.g., warfarin), and no prior overlapping radiation treatments.

What is being tested?

The trial is testing the addition of ferumoxytol (an iron supplement) and high-dose vitamin C to the usual chemoradiation treatment for brain tumors. All participants will receive these additional treatments alongside standard care with temozolomide chemotherapy and external beam radiation therapy.

What are the potential side effects?

Potential side effects include allergic reactions to ferumoxytol, increased risk of infection due to immune system suppression from chemotherapy, fatigue from radiation therapy, digestive issues from both chemo and high-dose vitamin C intake. Side effects can vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I do not have a major brain condition like multiple sclerosis.

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I can care for myself and am up more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation treatment in the same area before.

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I have G6PD deficiency.

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I need iron supplements for my health.

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My kidney function tests are within the required range.

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I require insulin for my diabetes.

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I am currently taking HIV medication.

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I have a history of hemochromatosis.

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I am currently taking warfarin, flecainide, methadone, amphetamines, quinidine, or chlorpropamide and cannot change my medication.

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I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months post-radiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months post-radiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months post-radiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of recommended phase 2 ferumoxytol dosing regimen

Secondary study objectives

Clinical response

Estimate Objective Response Rate (ORR)

Estimate overall survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment4 Interventions

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

Group II: Cohort 1 (starting)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

External beam radiation therapy

2009

Completed Phase 3

~520

Temozolomide

2010

Completed Phase 3

~1880