PVSRIPO in Recurrent Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT02986178|
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Biological: PVSRIPO||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase 2 Study of Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) in Recurrent WHO Grade IV Malignant Glioma Patients|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Polio/Rhinovirus Recombinant (PVSRIPO)
Polio/Rhinovirus Recombinant (PVSRIPO)
A single dose of an oncolytic polio/rhinovirus recombinant (PVSRIPO)
- Objective Radiographic Response Rate [ Time Frame: 24 months after initial PVSRIPO infusion and through study completion. ]Assess objective anti-tumor response based on iRANO criteria.
- Objective Radiographic Response Rate [ Time Frame: 36 months after initial PVSRIPO infusion and through study completion. ]Assess objective anti-tumor response based on iRANO criteria.
- Duration of Objective Radiographic Response [ Time Frame: 24 months after initial PVSRIPO infusion and through study completion. ]Assess time of confirmed response to confirmed progressive disease/death.
- Duration of Objective Radiographic Response [ Time Frame: 36 months after initial PVSRIPO infusion and through study completion. ]Assess time of confirmed response to confirmed progressive disease/death.
- Overall Survival [ Time Frame: 24 and 36 months after initial PVSRIPO infusion and through study completion. ]Overall Survival, relative to external control group(s)
- Landmark Survival [ Time Frame: 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 [ Time Frame: 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.
- Safety of PVSRIPO: proportion of patients who experience grade 3, 4, or 5 AEs [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986178
|Contact: Henry Friedman, MDfirstname.lastname@example.org|
|Contact: Andrea T Kelly, PhDemail@example.com|
|United States, California|
|UCSF Neurological Surgery||Recruiting|
|San Francisco, California, United States, 94941|
|Contact: Nicholas Butowski, MD 415-353-2966 firstname.lastname@example.org|
|Contact: Eduardo R Almaraz 415-514-5529 email@example.com|
|Principal Investigator: Nicholas Butowski|
|United States, Florida|
|Baptist MD Anderson Cancer Center||Recruiting|
|Jacksonville, Florida, United States, 32207|
|Contact: Robert Cavaliere@bmcjax.com, MD 904-202-7468 ResearchBMDA@bmcjax.com|
|Contact: Darlene Brabant 904.202.7468 firstname.lastname@example.org|
|Principal Investigator: Robert Cavaliere, MD|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: William T Curry, MD 617-755-4272 email@example.com|
|Contact: Josephine Cambillo 617-643-5495 firstname.lastname@example.org|
|Principal Investigator: William Curry, MD|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Patrick Wen, MD 617-632-2166 email@example.com|
|Contact: Julia Hayden 617-632-5571 ext 40162 firstname.lastname@example.org|
|Principal Investigator: Patrick Wen, MD|
|United States, North Carolina|
|Preston Robert Tisch Brain Tumor Center at Duke University||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Dina Randazzo, DO 919-684-5301 email@example.com|
|Contact: Stevie Threatt 919-684-3657 firstname.lastname@example.org|
|Principal Investigator: Dina Randazzo, DO|
|United States, Ohio|
|University Hospitals Cleveland Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Andrew Sloan 216-844-6054 email@example.com|
|Contact: Christopher Murphy 216-844-0024 firstname.lastname@example.org|
|Principal Investigator: Andrew Sloan, MD, FACS|
|Principal Investigator:||Dina Randazzo, DO||Duke University|