Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel for Recurrent Glioblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 37
Summary
- Conditions
- GBM
- Glioblastoma
- Glioblastoma Multiforme
- Glioblastoma, IDH-wildtype
- Gliosarcoma
- Recurrent Glioblastoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Eligible patients will undergo craniotomy for tumor resection. During the tumor resection, an initial low dose of paclitaxel will be given following sonication. In select patients, the sonication procedure will occur immediately after the test dose of chemotherapy is administered.The sonication devi...
Eligible patients will undergo craniotomy for tumor resection. During the tumor resection, an initial low dose of paclitaxel will be given following sonication. In select patients, the sonication procedure will occur immediately after the test dose of chemotherapy is administered.The sonication device will be implanted at the end of the procedure. About two weeks after surgery, patients will undergo sonication and albumin-bound paclitaxel administration with MRI to quantify extent of blood brain barrier opening. Sonication and administration of albumin-bound paclitaxel will continue every 3 weeks until disease progression. The planned ABX starting dose is 40 mg/m2 of ABX, to be escalated in the absence of significant toxicity up to 260 mg/m2. Blood samples for circulating tumor DNA will also be collected before and after each sonication.
Tracking Information
- NCT #
- NCT04528680
- Collaborators
- CarThera
- Bristol-Myers Squibb
- Lantheus Medical Imaging
- Investigators
- Study Chair: Roger Stupp, MD Northwestern University Principal Investigator: Adam M Sonabend, MD Northwestern University