PVSRIPO in Recurrent Malignant Glioma

Phase 2

Active, not recruiting

• Conditions: Malignant Glioma
• Interventions: Biological: PVSRIPO

• Registration Number: NCT02986178
• Lead Sponsor: Istari Oncology, Inc.

Brief Summary

This is a phase 2 study of oncolytic polio/rhinovirus recombinant (PVSRIPO) in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma.

Detailed Description

This is a Phase 2 study of oncolytic polio/rhinovirus recombinant (PVSRIPO) in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma. The objective of this study is to investigate the safety and efficacy (anti-tumor response and survival) of PVSRIPO in recurrent WHO grade IV malignant glioma.

Patients will be administered PVSRIPO intratumorally via convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. Retreatment with PVSRIPO is allowed, provided retreatment eligibility criteria are met.

All patients who receive PVSRIPO treatment will be included in efficacy and safety analyses.

Study Timeline

• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-08
• Study Start: 2017-06-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Polio/Rhinovirus Recombinant (PVSRIPO)	PVSRIPO	Polio/Rhinovirus Recombinant (PVSRIPO)

Primary Outcome Measures

Name	Time	Method
Objective Radiographic Response Rate	36 months after initial PVSRIPO infusion and through study completion.	Assess objective anti-tumor response based on iRANO criteria.
Duration of Objective Radiographic Response	36 months after initial PVSRIPO infusion and through study completion.	Assess time of confirmed response to confirmed progressive disease/death.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	24 and 36 months after initial PVSRIPO infusion and through study completion.	Overall Survival, relative to external control group(s)
Safety of PVSRIPO: proportion of patients who experience grade 3, 4, or 5 AEs	While on study; average of 12 to 36 months after initial PVSRIPO infusion.	Within each cohort for those randomized prior to protocol version 7, as well as for those patients retreated with PVSRIPO, the proportion of patients who experience grade 3, 4, or 5 AEs that are possibly, probably, and definitely related to protocol treatment will be estimated.
Landmark Survival	24 and 36 months post-infusion and through study completion.	Overall survival at 24 and 36 months and greater
Disease Control Rate Following PVSRIPO Infusion	24 and 36 months after initial PVSRIPO infusion and through study completion.	The percentage of patients classified as non-progressive by radiographic response based on standard criteria.

Trial Locations

Locations (6)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

UCSF Neurological Surgery; 🇺🇸 San Francisco, California, United States

Baptist MD Anderson Cancer Center; 🇺🇸 Jacksonville, Florida, United States

Preston Robert Tisch Brain Tumor Center at Duke University; 🇺🇸 Durham, North Carolina, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States