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Ferumoxytol + Vitamin C for Glioblastoma (XACT-Fe-GBM-01 Trial)
XACT-Fe-GBM-01 Trial Summary
This trial tests adding ferumoxytol & vitamin C to standard brain tumor treatment to see if it helps adults.
XACT-Fe-GBM-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowXACT-Fe-GBM-01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.XACT-Fe-GBM-01 Trial Design
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Who is running the clinical trial?
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- I have had radiation treatment in the same area before.My doctor says I am healthy enough for specific cancer treatments.I have G6PD deficiency.I am advised to undergo temozolomide and radiation therapy.I need iron supplements for my health.I am 18 years old or older.My kidney function tests are within the required range.I require insulin for my diabetes.I can take pills by mouth.I do not have a major brain condition like multiple sclerosis.My treatment will start within 6 weeks after my last surgery.I was recently diagnosed with glioblastoma or diffuse midline glioma.I am currently taking HIV medication.I have a history of hemochromatosis.I am currently taking warfarin, flecainide, methadone, amphetamines, quinidine, or chlorpropamide and cannot change my medication.I can care for myself and am up more than 50% of my waking hours.I do not have any uncontrolled illnesses.
- Group 1: Cohort 1 (starting)
- Group 2: Cohort 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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