What side effects are associated with this type of intervention?

Common treatments for glioblastoma include surgery, radiation therapy, and chemotherapy. Radiation therapy, often used in combination with chemotherapy, can cause side effects such as fatigue, headaches, hair loss, and skin changes in the treated area. Chemotherapy, particularly with drugs like temozolomide, can lead to nausea, vomiting, loss of appetite, and increased risk of infections due to lowered blood cell counts. These treatments aim to slow tumor growth and alleviate symptoms, but they come with significant side effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several treatments for glioblastoma, including surgery, radiation, and chemotherapy. Temozolomide is a commonly used chemotherapeutic agent that has shown efficacy in treating glioblastoma. Bevacizumab, an angiogenesis inhibitor, has also been approved for recurrent glioblastoma. While the context does not provide specific information on RAGE inhibitors like Azeliragon, it highlights the need for new treatments in glioblastoma, indicating ongoing research and trials to find more effective therapies.

What other types of research exist?

Promising novel alternatives to Azeliragon for glioblastoma patients in 2024 include: 1) Tumor Treating Fields (TTFields) - a non-invasive treatment modality that uses electric fields to disrupt cancer cell division. 2) CAR-T cell therapy - a form of immunotherapy where a patient's T cells are modified to target cancer cells. 3) Oncolytic virus therapy - using genetically modified viruses to selectively infect and kill cancer cells. 4) New targeted therapies such as EGFR inhibitors and IDH inhibitors, which target specific genetic mutations in glioblastoma cells. 5) Combination therapies involving immune checkpoint inhibitors (e.g., pembrolizumab) with other treatments like radiation or chemotherapy.

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Azeliragon for Glioblastoma

Phase 2

Waitlist Available

Research Sponsored by Cantex Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a pill called azeliragon along with radiation therapy for a fast-growing brain cancer called 'unmethylated' glioblastoma. This type of cancer doesn't respond well to standard chemotherapy. The pill might help radiation work better and slow down the cancer's growth.

Who is the study for?

Adults with a specific brain cancer called glioblastoma that hasn't spread, who haven't had certain other cancers or treatments, and whose major organs are functioning well. They must have had surgery for tumor removal but not just a needle biopsy. Participants need to be able to follow the study plan and agree to use birth control if they can have children.

What is being tested?

The trial is testing Azeliragon combined with radiation therapy as an initial treatment for glioblastoma without MGMT promoter methylation. It's in phase 2, which means it's checking safety and how well it might work after showing promise in earlier research.

What are the potential side effects?

Specific side effects of Azeliragon aren't listed here, but common ones from similar treatments include fatigue, nausea, headaches, and potential allergic reactions. Side effects from radiation may include skin irritation at the treatment site and tiredness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival

Secondary study objectives

Overall survival

Response rate

Steroid requirement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Daily oral azeliragonExperimental Treatment1 Intervention

Azeliragon to be administered once daily for several days before, during, and after radiation therapy.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glioblastoma treatments typically include surgery to remove the tumor, radiation therapy to kill cancer cells, and chemotherapy like temozolomide to damage cancer cell DNA. Azeliragon, a RAGE inhibitor, is being studied for its ability to block the receptor for advanced glycation end products (RAGE), which plays a role in inflammation and tumor growth. Targeting RAGE could potentially slow tumor progression and improve outcomes for glioblastoma patients.