Immune modulation using ultrasound for glioblastoma treatment
A Phase 2a Trial of Immune Modulation in Combination With Ultrasound-mediated Blood Brain Barrier Opening in Patients With Newly Diagnosed Glioblastoma
This study is testing a new way to treat glioblastoma by using ultrasound to help deliver immune-boosting drugs more effectively after radiation therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | radiation, balstilimab, botensilimab, doxorubicin |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05864534 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve treatment for newly diagnosed glioblastoma by using a novel device that employs ultrasound to temporarily open the blood-brain barrier, allowing for better delivery of immune-modulating drugs. Patients will have the Sonocloud-9 device implanted after completing radiation therapy, followed by cycles of intravenous administration of balstilimab, botensilimab, and liposomal doxorubicin. The study will assess the safety and feasibility of this approach, as well as its effectiveness in treating glioblastoma. MRI scans will be conducted to evaluate the extent of blood-brain barrier opening and the response to treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed glioblastoma that is IDH-wildtype and has an unmethylated MGMT promoter.
Not a fit: Patients who have previously received immunotherapy for glioblastoma or other conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance drug delivery to brain tumors, potentially improving outcomes for patients with glioblastoma.
How similar studies have performed: While the use of ultrasound to open the blood-brain barrier is a novel approach, similar studies have shown promise in enhancing drug delivery to brain tumors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Adam Sonabend, MD — Northwestern University
- Study coordinator: Neurological Surgery
- Email: braintumortrials@nm.org
- Phone: (312) 695-8143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.