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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months post-radiation
Awards & highlights

XACT-Fe-GBM-01 Trial 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.Check my eligibility
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.See study design
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.

XACT-Fe-GBM-01 Trial 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.

XACT-Fe-GBM-01 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of recommended phase 2 ferumoxytol dosing regimen
Secondary outcome measures
Clinical response
Estimate Objective Response Rate (ORR)
Estimate overall survival (OS)
+3 more

XACT-Fe-GBM-01 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
~1930

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,263 Total Patients Enrolled
314 Trials studying Glioblastoma
22,434 Patients Enrolled for Glioblastoma
Bryan AllenLead Sponsor
3 Previous Clinical Trials
119 Total Patients Enrolled
1 Trials studying Glioblastoma
90 Patients Enrolled for Glioblastoma
Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
765 Total Patients Enrolled
2 Trials studying Glioblastoma
90 Patients Enrolled for Glioblastoma

Media Library

External Beam Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04900792 — Phase 1
Glioblastoma Research Study Groups: Cohort 1 (starting), Cohort 2
Glioblastoma Clinical Trial 2023: External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT04900792 — Phase 1
External Beam Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04900792 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical purpose is Cohort 2 (-1 dose level) typically employed for?

"Cohort 2 (-1 dose level) is approved for treating catarrh and other issues such as vitamin deficiency, advanced directives, and refractory neuroblastoma."

Answered by AI

Has the second cohort (-1 dose level) of this product been approved by the FDA?

"Since this is an early-phase trial with a limited amount of data surrounding efficacy and safety, Cohort 2 (-1 dose level) received a score of 1."

Answered by AI

Can you elaborate on any other investigations that have been conducted with Cohort 2 (-1 dose level)?

"Currently, 254 clinical trials are researching Cohort 2 (-1 dose level). 33 of these live studies have reached Phase 3. Although the majority of investigations related to this remedy take place in Houston, Texas, there is a total of 4846 locations conducting research on its efficacy."

Answered by AI

Are researchers still accepting participants for this clinical investigation?

"Clinicaltrials.gov data verifies that this particular trial, which was initially posted on February 28th of 2023 is not actively recruiting patients. Fortunately, there are over 685 other trials with open enrollment at the moment."

Answered by AI

Does this clinical experiment represent a pioneering effort?

"Since the 2002 inception of Cohort 2 (-1 dose level), which was headed by Schering-Plough, this drug has received its Phase 2 approval. Currently, there are 254 trials related to Cohort 2 (-1 dose level) running across 1069 cities and 46 countries around the world."

Answered by AI

How many individuals are taking part in this medical trial?

"This clinical trial is no longer taking new enrolments, having been initially posted on February 28th 2023 and last updated January 17th of the same year. There are presently 431 trials recruiting patients with glioblastoma and 254 studies for Cohort 2 (-1 dose level) actively looking to add participants."

Answered by AI
~2 spots leftby Jun 2024