NCT03043391

Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children

Phase Ib Study of Oncolytic Polio/Rhinovirus Recombinant Against Recurrent Malignant Glioma in Children

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Istari Oncology, Inc. · Industry
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. The primary objective is to confirm the safety of the selected dose of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED) in children with recurrent WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma) or WHO Grade IV malignant glioma (glioblastoma, gliosarcoma). A secondary objective is to estimate overall survival (OS) in this population.

Detailed description

PVSRIPO will be delivered intratumorally by CED using an intracerebral catheter placed within the enhancing portion of the tumor. The population group are patients with recurrent WHO grade III or IV malignant glioma who are aged 12 through 21 years old. After a single dose of PVSRIPO, subjects will return for periodic visits to monitor tumor status, adverse events, and changes in blood immune profiles. A maximum of 12 pediatric patients will be treated with PVSRIPO, and then carefully monitored for safety for at least a year after treatment.

Conditions

• Malignant Glioma
• Anaplastic Astrocytoma
• Anaplastic Oligoastrocytoma
• Anaplastic Oligodendroglioma
• Glioblastoma
• Gliosarcoma
• Atypical Teratoid/Rhabdoid Tumor of Brain
• Medulloblastoma
• Ependymoma
• Pleomorphic Xanthoastrocytoma of Brain
• Embryonal Tumor of Brain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-07
• Primary completion: 2022-03-23
• Completion: 2022-03-23
• First posted: 2017-02-06
• Last updated: 2024-04-08
• Results posted: 2024-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study