RECRUITING

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2a Trial of Immune Modulation in Combination With Ultrasound-mediated Blood Brain Barrier Opening in Patients With Newly Diagnosed Glioblastoma

Quick Facts

Study Start:2024-01-31
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05864534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have newly diagnosed pathologically proven glioblastoma, isocitric dehydrogenase-1/2 wild-type
  2. * Tumor with methyl guanine methyl transferase (MGMT) gene promoter unmethylated
  3. * Available paraffin embedded tumor tissue for the study
  4. * Have completed standard radiotherapy with or without temozolomide
  5. * 18 years of age or older
  6. * Able to undergo contrast-enhanced MRI
  7. * Have an Eastern Cooperative Oncology Group/World Health Organization performance status ≤ 2
  8. * Size and location of the residual tumor and/or resection cavity must allow to be able to be covered by the sonication field
  9. * Have not received any prior treatment with immunotherapeutic agents treatments for glioblastoma or other indications
  10. * Have the ability to understand and willingness to sign a written informed consent prior to registration on study.
  11. * Be willing and able to comply with the protocol.
  12. * Have adequate organ and bone marrow function
  13. * Agree to use adequate contraception if appropriate
  1. * Multifocal tumor (unless all localized in a 50-mm diameter area accessible to ultrasound field) or tumor located in the posterior fossa.
  2. * Uncontrolled epilepsy.
  3. * Received other investigational agents within 2 weeks of registration
  4. * 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.
  5. * Contraindication to checkpoint inhibitor therapy (e.g., history of autoimmune disease)
  6. * Uncontrolled illness
  7. * History of active malignancy other than the brain tumor within 12 months prior to registration.
  8. * Are pregnant or breastfeeding.

Contacts and Locations

Study Contact

Christina Amidei
CONTACT
(312) 695-9124
christina.amidei@nm.org

Principal Investigator

Adam Sonabend, MD
PRINCIPAL_INVESTIGATOR
Northwestern University
Roger Stupp, MD
STUDY_DIRECTOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Adam Sonabend, MD, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Roger Stupp, MD, STUDY_DIRECTOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-31
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-01-31
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • Immunotherapy
  • Ultrasound
  • Blood-brain barrier
  • Sonocloud
  • Balstilimab (BAL)
  • Botensilimab (BOT)
  • Doxorubicin (DOX)

Additional Relevant MeSH Terms

  • Newly Diagnosed Glioblastoma
  • Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype
  • Gliosarcoma
  • Glioblastoma Multiforme