17 Participants Needed

Ferumoxytol + Vitamin C for Glioblastoma

(XACT-Fe-GBM-01 Trial)

VM
BG
Overseen ByBryan G. Allen, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Bryan Allen
Must be taking: Temozolomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JM

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

My doctor says I am healthy enough for specific cancer treatments.
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))
Agree to Lifestyle Considerations throughout study duration
See 8 more

Exclusion Criteria

I have had radiation treatment in the same area before.
History of Steven's Johnson Syndrome
I have G6PD deficiency.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Phase

Participants receive radiation therapy combined with temozolomide, ferumoxytol, and ascorbate

6-8 weeks
Daily visits for radiation, multiple IV infusions

Adjuvant Phase

Participants receive cycles of temozolomide and ascorbate, with initial ferumoxytol infusion

Up to 6 cycles (28 days each)
Regular visits for chemotherapy cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks post-radiation
Regular follow-up visits

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival

Up to 60 months for PFS, up to 20 years for OS

Treatment Details

Interventions

  • External Beam Radiation Therapy
  • Ferumoxytol Injection
  • Pharmacological Ascorbate
  • Temozolomide
Trial Overview 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.
Participant Groups
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.

External Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as External Beam Radiation Therapy for:
  • Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
🇺🇸
Approved in United States as External Beam Radiation Therapy for:
  • Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
🇨🇦
Approved in Canada as External Beam Radiation Therapy for:
  • Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
🇯🇵
Approved in Japan as External Beam Radiation Therapy for:
  • Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
🇨🇳
Approved in China as External Beam Radiation Therapy for:
  • Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
🇨🇭
Approved in Switzerland as External Beam Radiation Therapy for:
  • 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

Trials
4
Recruited
130+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Holden Comprehensive Cancer Center

Collaborator

Trials
27
Recruited
710+

Findings from Research

In a randomized trial involving 144 patients with anaplastic astrocytoma (AA) and glioblastoma (GBM), neoadjuvant temozolomide (NeoTMZ) did not show a survival advantage for the overall population or for GBM patients compared to radiotherapy alone.
However, patients with AA who received NeoTMZ had a significantly longer median survival of 95.1 months compared to 35.2 months for those receiving only radiotherapy, indicating a potential benefit of NeoTMZ specifically for AA.
Postoperative neoadjuvant temozolomide before radiotherapy versus standard radiotherapy in patients 60 years or younger with anaplastic astrocytoma or glioblastoma: a randomized trial.Malmström, A., Poulsen, HS., Grønberg, BH., et al.[2018]
In a study of 103 glioblastoma patients treated with standard temozolomide and radiotherapy, the median overall survival was found to be 13.7 months, highlighting the effectiveness of this treatment regimen.
Three key prognostic factors were identified that negatively impacted overall survival: age over 65 years, a Medical Research Council (MRC) scale score of 3-4, and the occurrence of postoperative complications, suggesting that these factors can help predict patient outcomes.
Age, Neurological Status MRC Scale, and Postoperative Morbidity are Prognostic Factors in Patients with Glioblastoma Treated by Chemoradiotherapy.Verlut, C., Mouillet, G., Magnin, E., et al.[2020]
In a study of 1157 glioblastoma multiforme patients, the addition of temozolomide (TMZ) to radiotherapy (RT) significantly improved median overall survival from 9.0 months with RT alone to 16.2 months with RT + TMZ (P < .001).
The two-year survival rate increased from 4% with RT alone to 25% with the combination of RT and TMZ, confirming the efficacy of TMZ in enhancing survival outcomes in GBM patients.
A population-based study on the effect of temozolomide in the treatment of glioblastoma multiforme.Rønning, PA., Helseth, E., Meling, TR., et al.[2022]

References

Postoperative neoadjuvant temozolomide before radiotherapy versus standard radiotherapy in patients 60 years or younger with anaplastic astrocytoma or glioblastoma: a randomized trial. [2018]
Age, Neurological Status MRC Scale, and Postoperative Morbidity are Prognostic Factors in Patients with Glioblastoma Treated by Chemoradiotherapy. [2020]
A population-based study on the effect of temozolomide in the treatment of glioblastoma multiforme. [2022]
Clinical outcome of concomitant chemoradiotherapy followed by adjuvant temozolomide therapy for glioblastaomas: single-center experience. [2018]
Phase II study of temozolomide and thalidomide with radiation therapy for newly diagnosed glioblastoma multiforme. [2018]
Temozolomide in radio-chemotherapy combined treatment for newly-diagnosed glioblastoma multiforme: phase II clinical trial. [2018]
Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal&#174;) in glioma patients in China. [2021]
Clinical and Genetic Factors Associated With Severe Hematological Toxicity in Glioblastoma Patients During Radiation Plus Temozolomide Treatment: A Prospective Study. [2018]
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]
Magnetite nanoparticles as a kinetically favorable source of iron to enhance GBM response to chemoradiosensitization with pharmacological ascorbate. [2023]
Pharmacological Strategy for Selective Targeting of Glioblastoma by Redox-active Combination Drug - Comparison With the Chemotherapeutic Standard-of-care Temozolomide. [2021]
Do Anti-Oxidants Vitamin D3, Melatonin, and Alpha-Lipoic Acid Have Synergistic Effects with Temozolomide on Cultured Glioblastoma Cells? [2023]
Combined temozolomide and radiation as an initial treatment for anaplastic glioma. [2018]
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