Ferumoxytol + Vitamin C for Glioblastoma

(XACT-Fe-GBM-01 Trial)

This trial explores whether adding ferumoxytol (an iron-based drug) and vitamin C to the usual treatment helps fight glioblastoma, a type of brain cancer. Participants will receive these additions along with standard treatments like radiation and the chemotherapy drug temozolomide. The trial aims to determine if this new combination is safe and potentially more effective. It seeks individuals recently diagnosed with glioblastoma who are about to start their first round of treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

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.

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.

Research has shown that ferumoxytol, a type of iron particle, is FDA-approved for treating iron deficiency anemia, indicating general safety for humans. However, its use with high-dose vitamin C remains under study. Some studies have examined the effectiveness of this combination with temozolomide, a chemotherapy drug, and radiation therapy.

Research has also explored the safety of using ferumoxytol and vitamin C together, focusing on optimal dosing and potential side effects. So far, no major issues have emerged, but it's important to note that this is still in the early stages of testing, so not all possible side effects are known.

Researchers are excited about the combination of ferumoxytol and vitamin C for glioblastoma because it introduces a novel approach to treating this aggressive brain cancer. Unlike standard treatments that typically rely on chemotherapy and radiation alone, this investigational treatment uses ferumoxytol, an iron supplement, to enhance the effects of radiation therapy. Additionally, high-dose vitamin C is administered intravenously, which may boost the body's ability to fight cancer cells. This combination could potentially improve the effectiveness of existing treatments, offering new hope for better outcomes in glioblastoma patients.

Research shows that adding temozolomide to radiation therapy can significantly improve survival rates for glioblastoma patients. Studies have found that this combination increases the ten-year survival rate from 47% to 70% and extends the average survival time compared to radiation alone.