What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, particularly those involving Bevacizumab, can lead to several side effects. Bevacizumab, an anti-angiogenic agent, is associated with hypertension, bleeding risks, thromboembolic events, gastrointestinal perforations, and wound healing issues. When combined with chemotherapy agents such as temozolomide, additional side effects may include myelosuppression, fatigue, nausea, and increased infection risk. These side effects are important to consider in the overall management of Glioblastoma.

What prior FDA approvals exist?

Bevacizumab, an anti-angiogenic agent, has been FDA-approved for the treatment of recurrent Glioblastoma due to its ability to inhibit VEGF and reduce tumor blood vessel growth. This is similar to the Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab being studied. Additionally, temozolomide, an oral chemotherapy drug, is commonly used in combination with radiation therapy for Glioblastoma treatment. These therapies aim to manage tumor growth and improve patient survival.

What other types of research exist?

Promising novel alternatives for Glioblastoma treatment in 2024 include: 1) Atezolizumab plus Bevacizumab, which has shown significant responses in other cancers and is being explored for glioblastoma. 2) CAR-T cell therapy targeting specific tumor antigens, which is an emerging immunotherapy approach. 3) Tumor Treating Fields (TTF), a non-invasive treatment that uses electric fields to disrupt cancer cell division. 4) Combination therapies involving immune checkpoint inhibitors (e.g., pembrolizumab) with other agents to enhance anti-tumor immune response. These alternatives are under investigation and may offer new hope for glioblastoma patients.

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Monoclonal Antibodies

SIACI Bevacizumab + Temozolomide and Radiation for Glioblastoma

Phase 3

Recruiting

Led By John Boockvar, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

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

Must have

Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control

Subject has a Karnofsky Performance Status (KPS) 70% or greater

Must not have

Subject, if female, is pregnant or is breastfeeding

Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 62 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a new treatment for aggressive brain cancer by using Mannitol to open the brain's barrier and then delivering Bevacizumab directly into the brain's arteries. It aims to improve survival rates for patients with newly diagnosed Glioblastoma Multiforme. Bevacizumab, typically administered intravenously, has shown superior outcomes when delivered directly into the brain's arteries in patients with recurrent Glioblastoma Multiforme.

Who is the study for?

This trial is for adults over 18 with newly diagnosed GBM brain cancer, expected to live at least 6 months. They must be able to have an MRI, use birth control if of reproductive potential, and sign consent. Participants need normal blood counts and organ function, a specific diagnosis of GBM per WHO criteria, and a Karnofsky Performance Status of 70% or higher.

What is being tested?

The study compares two treatments for GBM: one group receives standard Temozolomide with Radiation; the other gets an additional treatment called SIACI Bevacizumab (Avastin) alongside Temozolomide and Radiation. The goal is to see if SIACI increases survival without disease progression or overall lifespan compared to the standard therapy.

What are the potential side effects?

Potential side effects include complications from intraarterial infusion like stroke or bleeding in the brain, as well as those associated with Bevacizumab such as high blood pressure, bleeding problems, wound healing complications, kidney issues and immune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant and agree to use birth control.

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I am mostly able to care for myself and carry out daily activities.

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My brain tumor is confirmed as GBM, IDH-wild type, according to 2021 WHO standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

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I have started treatment for glioblastoma.

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My scans show cancer has spread to multiple areas or the lining of my brain/spine.

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I am currently being treated for an infection.

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I don't have any health conditions that could risk my safety or affect the study.

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My brain tumor is not a glioblastoma but has an IDH mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 62 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~62 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 62 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall survival (OS)

Secondary study objectives

Progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SIACI of Bevacizumab (Avastin) with Temozolomide and RadiationExperimental Treatment1 Intervention

Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation

Group II: Standard of care Temozolomide and RadiationActive Control1 Intervention

Standard of care Temozolomide and Radiation

0 / 9Eligibility criteria met

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 (GBM) is a highly aggressive brain tumor with poor prognosis. Common treatments include surgery, radiation therapy, and chemotherapy. Bevacizumab, an anti-angiogenic agent, is used to inhibit the growth of blood vessels that supply the tumor, thereby starving it of nutrients and slowing its growth. The Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab aims to deliver the drug directly to the tumor site, potentially increasing its efficacy and reducing systemic side effects. This targeted approach is crucial for GBM patients as it may improve survival rates and quality of life by more effectively controlling tumor growth and minimizing adverse effects.