Study on the Safety and Effectiveness of Bevacizumab with NaviFUS System for Treating Recurrent Glioblastoma Multiforme

Sponsor: NaviFUS Corporation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06329570

Provider View

This clinical trial is exploring a new treatment combining Bevacizumab and a focused ultrasound system to see if it is safe and effective for patients with recurrent glioblastoma multiforme, a type of brain cancer.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with recurrent glioblastoma multiforme (rGBM), a type of brain cancer that has returned after initial treatment. The treatment combines Bevacizumab, a medication used to treat rGBM, with a special ultrasound system that uses microbubbles to target the brain tumor. The goal is to see if this combination is safe and can help control the cancer.

Description

In this study, up to 10 patients with recurrent glioblastoma multiforme (rGBM) will receive a combination of Bevacizumab and a focused ultrasound system with microbubbles. Bevacizumab is given through an IV infusion, and after a short wait, microbubbles are administered to help the ultrasound target the tumor more effectively. This treatment is repeated every two weeks for up to 34 weeks, or until the cancer progresses, side effects become too severe, or the patient decides to stop participating. Patients will be closely monitored for safety and effectiveness throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Body mass index (BMI) of at least 17 kg/m2.
  • Diagnosed with glioblastoma that has returned, confirmed by MRI.
  • May have had surgery for the returning cancer and must be recovered from it.
  • Must have had at least 80% of the tumor removed or have a small remaining tumor.
  • If taking steroids, the dose must be stable or decreasing for at least a week before starting treatment.
  • Must have recovered from previous treatments, such as surgery or chemotherapy, within specific timeframes.
  • Life expectancy of at least 12 weeks.
  • Good overall health with a performance status of 70 or higher.
  • Adequate blood, kidney, liver, and clotting function based on specific tests.
  • The area for ultrasound treatment must be close to the brain surface.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must be able to receive Bevacizumab through an IV and have hair shaved in the treatment area.
  • Must provide informed consent and agree to follow study procedures.

Exclusion Criteria

  • Have multiple tumor sites in the brain.
  • Have had previous treatment with Bevacizumab or similar drugs.
  • Have had certain types of brain surgery or treatments.
  • Have significant heart disease or recent heart attack.
  • Have had a stroke within the last 6 months.
  • Have electronic devices implanted in the body.
  • Have uncontrolled high blood pressure.
  • Have a history of blood clots or bleeding disorders.
  • Have severe lung disease or recent lung problems.
  • Have mental health issues that affect study participation.
  • Have active infections or other serious medical conditions.
  • Are pregnant or breastfeeding.
  • Have allergies to study medications or components.
  • Use recreational drugs or have a history of drug addiction.
  • Have any other condition that might increase risk or affect study results.

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