Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Launched by NORTHWESTERN UNIVERSITY · May 9, 2023

Keywords

ClinConnect Summary

**Clinical Trial Summary: Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma**

This clinical trial is testing a new way to treat glioblastoma, a type of aggressive brain tumor. Researchers are using a special device that emits ultrasound to temporarily open the blood-brain barrier (BBB), which is like a protective shield that keeps drugs from easily entering the brain. By opening this barrier, doctors hope that immune-modulating drugs can better reach the tumor and help improve treatment outcomes. The device will be implanted after patients complete their standard radiation therapy, and the immune-modulating drugs will be given every three weeks while the device is activated.

To participate in this trial, patients must be at least 18 years old and have a newly diagnosed glioblastoma, along with specific genetic characteristics. They should have completed their initial radiation treatment and must be able to undergo an MRI scan. However, patients with certain conditions, such as uncontrolled epilepsy or previous treatments for glioblastoma, may not be eligible. Participants will be closely monitored for safety, and the trial aims to determine if this innovative approach is both safe and effective in fighting glioblastoma. If you or someone you know is interested in this trial, it’s important to discuss it with a healthcare provider to see if it’s a good fit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have newly diagnosed pathologically proven glioblastoma, isocitric dehydrogenase-1/2 wild-type
• • Tumor with methyl guanine methyl transferase (MGMT) gene promoter unmethylated
• • Available paraffin embedded tumor tissue for the study
• • Have completed standard radiotherapy with or without temozolomide
• • 18 years of age or older
• • Able to undergo contrast-enhanced MRI
• • Have an Eastern Cooperative Oncology Group/World Health Organization performance status ≤ 2
• • Size and location of the residual tumor and/or resection cavity must allow to be able to be covered by the sonication field
• • Have not received any prior treatment with immunotherapeutic agents treatments for glioblastoma or other indications
• • Have the ability to understand and willingness to sign a written informed consent prior to registration on study.
• • Be willing and able to comply with the protocol.
• • Have adequate organ and bone marrow function
• • Agree to use adequate contraception if appropriate
• Exclusion Criteria: Patients will be ineligible if they have:
• • Multifocal tumor (unless all localized in a 50-mm diameter area accessible to ultrasound field) or tumor located in the posterior fossa.
• • Uncontrolled epilepsy.
• • Received other investigational agents within 2 weeks of registration
• • Received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.
• • Contraindication to checkpoint inhibitor therapy (e.g., history of autoimmune disease)
• • Uncontrolled illness
• • History of active malignancy other than the brain tumor within 12 months prior to registration.
• • Are pregnant or breastfeeding.