Vaccine Therapy + Temozolomide for Glioblastoma

This trial tests the effectiveness of a vaccine therapy (SVN53-67/M57-KLH Peptide Vaccine) combined with the chemotherapy drug temozolomide for individuals with newly diagnosed glioblastoma, an aggressive brain cancer. The vaccine aims to trigger the immune system to attack cancer cells, while temozolomide stops these cells from growing and spreading. Researchers seek to determine if the combination is more effective than temozolomide alone. Suitable participants have a confirmed glioblastoma diagnosis and have completed initial radiation and chemotherapy treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial does not specify if you need to stop taking your current medications. However, you cannot receive other treatments for your tumor besides temozolomide, and you must not have received any immunotherapy for your brain tumor.

Research has shown that the SVN53-67/M57-KLH peptide vaccine, known as SurVaxM, is generally safe and well-tolerated. In previous studies, patients with recurring or worsening malignant glioma (a type of brain tumor) received this vaccine without major safety concerns. These studies reported no serious side effects directly linked to the vaccine.

Temozolomide, a chemotherapy drug approved by the FDA for treating glioblastoma, is generally considered safe, especially when used as an additional treatment after radiation. Some side effects, such as low blood cell counts, can occur but are usually manageable.

Unlike the standard treatments for glioblastoma, which typically involve surgery, radiation, and the chemotherapy drug temozolomide, the investigational treatment in this trial includes a vaccine called SVN53-67/M57-KLH. This vaccine is designed to stimulate the immune system to specifically target and attack glioblastoma cells, potentially offering a more targeted approach. Researchers are excited about this treatment because it combines the established efficacy of temozolomide with the innovative potential of an immune-based therapy, which could lead to improved outcomes for patients with this aggressive brain cancer. This combination aims to enhance the body's natural defenses against the tumor, providing a novel and promising strategy in the fight against glioblastoma.

In this trial, participants will receive a combination of the SurVaxM vaccine and the chemotherapy drug temozolomide to treat glioblastoma, a type of brain cancer. Research has shown that patients who received SurVaxM lived for a median of 21.8 months, with 26% surviving for three years, surpassing past results. SurVaxM helps the immune system attack cancer cells without causing major side effects. Temozolomide, a common chemotherapy drug, improves survival when combined with radiation therapy. Together, these treatments might offer a more effective way to fight glioblastoma.¹²⁵⁶⁷