Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma (NCT05864534) | Clinical Trial Compass
RecruitingPhase 2
Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
United States25 participantsStarted 2024-01-19
Plain-language summary
Brain tumor treatment is hampered by the blood-brain barrier (BBB). This barrier prevents drugs carried in the bloodstream from getting into the brain. If the BBB can be opened, making it temporarily more permeable, drugs may able to better reach the brain tumor. In this trial we will implant a novel device with 9 ultrasound emitters, allowing temporary and reversible opening of the BBB to maximize brain penetration of drugs that modulate the immune system. The device will be implanted after radiation is completed. Immune modulating drugs will be given every 3 weeks in conjunction with activation of the device to open the BBB.
The objectives of this trial are to establish whether it is safe and feasible to administer immune modulating drugs in this manner, and identify whether the treatment is effective in treating glioblastoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 inhib…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.