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PVSRIPO for Recurrent Glioblastoma (GBM)

NCT01491893 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-09-28

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)

Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Brain Tumor Research Charity Grant

    collaborator UNKNOWN

  • Duke University

    collaborator OTHER

  • Istari Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Landi, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-25
Primary Completion
2017-06-27
Completion
2021-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01491893 on ClinicalTrials.gov