8
Participants
Start Date
November 7, 2017
Primary Completion Date
March 23, 2022
Study Completion Date
March 23, 2022
Polio/Rhinovirus Recombinant (PVSRIPO)
PVSRIPO will be delivered intratumorally by convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. A stereotactic biopsy will be performed prior to virus administration. Immediately following the stereotactically-guided tumor biopsy, a catheter will be implanted in the operating room at a site the same or different from that used for the biopsy using sterile techniques under general anesthesia. The entire volume of PVSRIPO to be delivered will be pre-loaded into a syringe by the investigational pharmacist and connected to the catheter under sterile conditions in the Pediatric Intensive Care Unit (PICU) just prior to beginning of infusion.
Duke University Medical Center, Durham
Lead Sponsor
Collaborators (1)
Solving Kids' Cancer
OTHER
The Andrew McDonough B+ Foundation
OTHER
Duke University
OTHER
Istari Oncology, Inc.
INDUSTRY