Ferumoxytol + Vitamin C for Glioblastoma
(XACT-Fe-GBM-01 Trial)
Trial Summary
Do I have to stop taking my current medications?
The trial requires stopping certain medications. You cannot participate if you are currently using warfarin, flecainide, methadone, amphetamines, quinidine, chlorpropamide, or antiretroviral drugs and cannot switch or stop them. If you need insulin or iron supplements, you also cannot participate. Over-the-counter iron supplements are okay.
Will I have to stop taking my current medications?
The trial requires you to stop taking certain medications, such as warfarin, flecainide, methadone, amphetamines, quinidine, chlorpropamide, and antiretroviral drugs, unless a substitution is possible. If you are on these medications and cannot switch, you may not be eligible to participate.
What data supports the idea that Ferumoxytol + Vitamin C for Glioblastoma is an effective treatment?
The available research does not provide specific data on the effectiveness of Ferumoxytol + Vitamin C for treating Glioblastoma. Instead, the studies focus on the use of another drug, Temozolomide, combined with radiation therapy, which has been shown to improve survival rates for patients with Glioblastoma. This suggests that Temozolomide with radiation is a well-documented and effective treatment option for this condition. Without specific data on Ferumoxytol + Vitamin C, it's unclear how it compares to the established treatment of Temozolomide and radiation.12345
What data supports the effectiveness of the drug combination of Ferumoxytol, Vitamin C, and Temozolomide for treating glioblastoma?
Research shows that Temozolomide, when used with radiation therapy, improves survival in patients with glioblastoma. This suggests that combining Temozolomide with other treatments like Ferumoxytol and Vitamin C might also be beneficial, although specific data on this exact combination is not available.12345
What safety data exists for the treatment of Ferumoxytol + Vitamin C for Glioblastoma?
The provided research primarily discusses the safety and toxicity of Temozolomide (TMZ) in combination with radiation therapy for glioblastoma treatment. Temozolomide is generally considered safe but can cause side effects such as fatigue, nausea, vomiting, thrombocytopenia, and neutropenia. Severe myelotoxicity, including myelodysplastic syndrome or aplastic anemia, is rare but has been reported. There is no specific safety data provided for the combination of Ferumoxytol and Vitamin C in the treatment of glioblastoma in the given research.56789
Is the combination of Ferumoxytol and Vitamin C safe for treating glioblastoma?
Temozolomide, a drug often used with radiation therapy for glioblastoma, is generally considered safe but can cause side effects like fatigue, nausea, and blood-related issues. Severe blood problems are rare but have been reported. No specific safety data for Ferumoxytol and Vitamin C combination in glioblastoma is available from the provided research.56789
Is the treatment External Beam Radiation Therapy and the drug Temozolomide promising for glioblastoma?
Yes, combining External Beam Radiation Therapy with the drug Temozolomide is promising for treating glioblastoma. This combination has shown to improve tumor control and enhance the effectiveness of treatment, especially when used with other supportive therapies like Ferumoxytol and Vitamin C.110111213
What makes the Ferumoxytol + Vitamin C treatment for glioblastoma unique?
This treatment is unique because it combines Ferumoxytol, a type of iron nanoparticle, with high doses of Vitamin C to enhance the effectiveness of standard chemotherapy and radiation therapy. The combination works by increasing the production of hydrogen peroxide, which selectively kills cancer cells more effectively than normal cells.110111213
What is the purpose of this trial?
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.
Research Team
John M. Buatti, MD
Principal Investigator
University of Iowa
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation Phase
Participants receive radiation therapy combined with temozolomide, ferumoxytol, and ascorbate
Adjuvant Phase
Participants receive cycles of temozolomide and ascorbate, with initial ferumoxytol infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival
Treatment Details
Interventions
- External Beam Radiation Therapy
- Ferumoxytol Injection
- Pharmacological Ascorbate
- Temozolomide
External Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bryan Allen
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Holden Comprehensive Cancer Center
Collaborator