CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 enrolled
Drug / intervention
Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01491893
NCT01491893Phase 1Completed
CompareCT.gov

Dose-finding and Safety Study of an Oncolytic Polio/Rhinovirus Recombinant Against Recurrent WHO Grade IV Malignant Glioma

Istari Oncology, Inc.·interventional·Posted Dec 14, 2011·Updated Sep 28, 2023

In Brief

A Phase 1 clinical trial evaluating Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO) for GBM and 3 related conditions. Completed, enrolled 61 participants across 1 site.

Detailed Summary

Purpose of the Study: To determine the maximally tolerated dose (MTD) and the Recommended Phase 2 Dose (RP2D) of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED). To obtain correlative mechanistic evidence of PVSRIPO's effects on infected WHO Grade IV malignant glioma tumors and to estimate progression-free survival (PFS) and overall survival (OS) in recurrent WHO Grade IV malignant glioma patients. To obtain information about clinical response rates to intratumoral inoculation of PVSRIPO. To estimate the efficacy of PVSRIPO administered at the optimal dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGBM, Glioblastoma, Glioma, Malignant Glioma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Brain Tumor Research Charity Grant, Duke University

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2011
Enrollment StartApr 25, 2012
Primary CompletionJun 27, 2017
Study CompletionOct 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 14.5 years ago

Interventions

Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)biological

Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)