Recruitment

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