Clinical Trial: Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary: 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 between the ages of 12 and 17. 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.
Sponsor: Darell D. Bigner, MD, PhD

Current Primary Outcome: Percentage of participants with unacceptable toxicity [ Time Frame: 14 days after treatment with PVSRIPO ]

Percentage of participants with unacceptable toxicity during the 14-day period post-PVSRIPO treatment


Original Primary Outcome: Same as current

Current Secondary Outcome: 24-month overall survival [ Time Frame: 24 months after administration of PVSRIPO ]

The percentage of participants alive at 24 months after the administration of PVSRIPO. Overall survival is defined as the time from the date of administration of PVSRIPO until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: February 2, 2017
Date Started: June 1, 2017
Date Completion: July 1, 2021
Last Updated: May 30, 2017
Last Verified: May 2017