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.

Timeline

Start

2017-11-07

Primary completion

2022-03-23

Completion

2022-03-23

Publications

• Barkley A, Butler E, Park C, Friedman A, Landi D, Ashley DM, Bigner D, Bernstock JD, Friedman GK, Johnston JM, Thompson EM. The safety and accuracy of intratumoral catheter placement to infuse viral immunotherapies in children with malignant brain tumors: a multi-institutional study. J Neurosurg Pediatr. 2024 Jan 12;33(4):359-366. doi: 10.3171/2023.12.PEDS23404. Print 2024 Apr 1.
• Thompson EM, Landi D, Brown MC, Friedman HS, McLendon R, Herndon JE 2nd, Buckley E, Bolognesi DP, Lipp E, Schroeder K, Becher OJ, Friedman AH, McKay Z, Walter A, Threatt S, Jaggers D, Desjardins A, Gromeier M, Bigner DD, Ashley DM. Recombinant polio-rhinovirus immunotherapy for recurrent paediatric high-grade glioma: a phase 1b trial. Lancet Child Adolesc Health. 2023 Jul;7(7):471-478. doi: 10.1016/S2352-4642(23)00031-7. Epub 2023 Mar 30.

Drugs

Indications