NaviFUS + Bevacizumab for Glioblastoma

Overseen By UCCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Must not be taking: VEGF inhibitors

Disqualifiers: Congestive heart failure, Hypertension, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating recurring glioblastoma, a type of brain cancer, by combining a device called NaviFUS with the medication Bevacizumab, an anti-cancer drug. The researchers aim to determine if this combination is safe and shows early signs of effectiveness. Suitable candidates have experienced a return of glioblastoma after radiation and chemotherapy and currently have a measurable tumor. Participants must tolerate minor procedures, such as receiving an IV, and be willing to have part of their head shaved. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment approach.

Will I have to stop taking my current medications?

The trial requires a minimum interval since your last drug therapy: 1 week for non-cytotoxic agents or daily chemotherapy, 4 weeks for cytotoxic therapy, and 6 weeks for nitrosourea-containing chemotherapy. If you're on steroids, you must be on a stable dose for at least 7 days before starting the study treatment.

What prior data suggests that the NaviFUS system with bevacizumab is safe for glioblastoma patients?

Research shows that the NaviFUS system, combined with bevacizumab (a drug that helps control the blood supply to tumors), is undergoing testing for safety and effectiveness in patients with recurrent glioblastoma, a type of brain cancer. Studies have found that bevacizumab is generally safe and can delay cancer progression.

Early results from other research suggest that the NaviFUS system may enhance bevacizumab's ability to reach the tumor. This combination has been well-tolerated, with no unexpected safety issues reported so far.

However, these findings remain in the early stages. More research is necessary to fully understand the safety of this treatment combination. Always consult a healthcare provider to understand what joining a trial might mean. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of NaviFUS and bevacizumab for treating glioblastoma because it offers a novel approach to tackling this aggressive brain cancer. Unlike standard treatments like surgery, radiation, and chemotherapy, which primarily focus on removing or killing cancer cells directly, this approach uses a targeted technique. NaviFUS uses focused ultrasound to temporarily open the blood-brain barrier, potentially allowing bevacizumab—a drug that inhibits blood vessel growth in tumors—to penetrate the brain more effectively. This method could enhance drug delivery to hard-to-reach tumor areas, offering hope for improved outcomes in a condition that is notoriously difficult to treat.

What evidence suggests that the NaviFUS system with bevacizumab is effective for glioblastoma?

This trial will evaluate the combination of NaviFUS with bevacizumab for treating recurring glioblastoma (GBM), an aggressive brain cancer. Studies have shown that this combination can help treat GBM. Research indicates that the NaviFUS system can safely open the blood-brain barrier, allowing bevacizumab to reach the tumor more effectively. Bevacizumab slows tumor growth by blocking the formation of new blood vessels. Early trials with this combination demonstrated survival benefits in laboratory settings. This promising therapy aims to improve outcomes for patients with this challenging condition. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with recurrent glioblastoma, a type of brain cancer. Specific eligibility details are not provided, but typically participants must meet certain health standards and have no conditions that would interfere with the study.

Inclusion Criteria

I am 18 years old or older.

Must have measurable disease ≥ 10mm (according to RANO criteria).

I can care for myself but may need occasional help.

Exclusion Criteria

Pregnant or breast-feeding women.

Known sensitivity/allergy to MRI contrast agents, CT contrast agents, SonoVue® [Lumason®], bevacizumab, or any of their components.

Any other condition that, in the Investigator's judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NaviFUS system with concomitant microbubble administration in conjunction with bevacizumab (BEV) for the treatment of recurrent glioblastoma multiforme (rGBM)

24 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events, physical and neurological examinations, and quality of life

6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Bevacizumab

Trial Overview

The trial tests the NaviFUS system's safety and early effectiveness when used alongside Lumason microbubbles and Bevacizumab (BEV) in treating recurrent glioblastoma.

How Is the Trial Designed?

Group I: NaviFUS + bevacizumab Experimental Treatment 3 Interventions

NaviFUS system with concomitant microbubble administration in conjunction with bevacizumab (BEV)

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

NaviFUS Corporation

Industry Sponsor

Trials

10

Recruited

120+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07274787

Safety And Effectiveness Of NaviFUS System With ...

This study will evaluate the safety and early effectiveness of the NaviFUS system with concomitant microbubble administration in conjunction ...

2.

navifus.com

navifus.com/2020/03/30/navifus-bevacizumab-clinical-trial-approved/

Combination NaviFUS System and Bevacizumab Clinical ...

The trial consisted of six patients with Recurrent Glioblastoma (rGBM), and results showed that the system can precisely open the blood-brain ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10639546/

CTNI-63. A PHASE IIA CLINICAL TRIAL FOR ...

This study aims to evaluate the safety and efficacy of BEV + MB-FUS for treating patients with rGBM.

4.

journals.lww.com

journals.lww.com/neurosurgery/fulltext/9900/combination_of_neuronavigation_guided_focused.1959.aspx

Combination of Neuronavigation-Guided Focused ...

Combining focused ultrasound (FUS)–induced blood-brain barrier opening with bevacizumab (BEV) has demonstrated survival benefits in preclinical ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06329570

NCT06329570 | Safety and Efficacy of Bevacizumab in ...

The study aims to demonstrate the high safety profile and effectiveness of BEV+FUS-MB targeted therapy for brain tumors. Any patient with a histological ...

6.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/513577

A Prospective Pivotal Study to Evaluate the Efficacy and ...

Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging ...

7.

navifus.com

navifus.com/2021/08/18/gbm-results-of-navifus-system-bevacizumab/

GBM Workshop 2021 – Preliminary Results of the ...

NaviFUS system combined with bevacizumab shows promise for enhancing drug delivery and potentially increasing survival in rGBM.