Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05864534
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Balstilimab — DRUG
    Balstilimab 450 mg IV over 30 minutes every 3 weeks
  • Botensilimab — DRUG
    Botensilimab1mg/kg mg IV over 30 minutes every 6 weeks
  • Liposomal Doxorubicin — DRUG
    Liposomal Doxorubicin 30 mg IV over 30 minutes every 3 weeks
  • Sonocloud-9 (SC-9) — DEVICE
    Device activation of 9 ultrasound emitters during IV injection of microbubbles every 3 weeks

Study Details

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.

Key Dates

Start date
Jan 19, 2024
Status verified
Sep 2025
Primary completion
Jul 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Blood-brain barrier opening with concomitant BAL, BOT, DOX
    Patients will undergo implantation of Sonocloud-9 after completion of radiotherapy. Within 21 days after implant, ultrasound-based BBB opening with concomitant administration of DOX (30 mg) + BAL (450 mg) every 3 weeks, and BOT (dose 1mg/kg) every 6 weeks will be initiated.

Primary Outcome Measure

Unacceptable toxicity rate [ Time Frame: 42 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Neurological Surgery
[email protected]
(312) 695-8143

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By research site
Northwestern University· Chicago, IL

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