Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

November 7, 2017

Primary Completion Date

March 23, 2022

Study Completion Date

March 23, 2022

Conditions
Malignant GliomaAnaplastic AstrocytomaAnaplastic OligoastrocytomaAnaplastic OligodendrogliomaGlioblastomaGliosarcomaAtypical Teratoid/Rhabdoid Tumor of BrainMedulloblastomaEpendymomaPleomorphic Xanthoastrocytoma of BrainEmbryonal Tumor of Brain
Interventions
BIOLOGICAL

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.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Solving Kids' Cancer

OTHER

collaborator

The Andrew McDonough B+ Foundation

OTHER

collaborator

Duke University

OTHER

lead

Istari Oncology, Inc.

INDUSTRY

NCT03043391 - Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children | Biotech Hunter | Biotech Hunter