Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children

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.

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

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.

Sponsors & Collaborators

• Solving Kids' Cancer

  collaborator OTHER

• The Andrew McDonough B+ Foundation

  collaborator OTHER

• Duke University

  collaborator OTHER

• Istari Oncology, Inc.

  lead INDUSTRY

Principal Investigators

• Darell Bigner, MD, PhD · Istari Oncology, Inc.

• Daniel Landi, MD · Duke University

• Eric Thompson, MD · Duke University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-07

Primary Completion

2022-03-23

Completion

2022-03-23

FDA Drug

Yes

Countries

• United States

Study Locations