Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03043391|
Recruitment Status : Active, not recruiting
First Posted : February 6, 2017
Last Update Posted : July 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma Anaplastic Astrocytoma Anaplastic Oligoastrocytoma Anaplastic Oligodendroglioma Glioblastoma Gliosarcoma Atypical Teratoid/Rhabdoid Tumor of Brain Medulloblastoma Ependymoma Pleomorphic Xanthoastrocytoma of Brain Embryonal Tumor of Brain||Biological: Polio/Rhinovirus Recombinant (PVSRIPO)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase Ib study to evaluate feasibility, safety, and preliminary evidence of efficacy of the optimal adult dose in a pediatric population|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Study of Oncolytic Polio/Rhinovirus Recombinant Against Recurrent Malignant Glioma in Children|
|Actual Study Start Date :||December 5, 2017|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||March 1, 2022|
Experimental: Polio/Rhinovirus Recombinant (PVSRIPO)
PVSRIPO is an altered form of the live polio vaccine. It was produced by removing a piece of the virus and replacing it with a piece from a common cold virus. This was done to make sure PVSRIPO cannot cause polio even when injected into the brain.
Biological: Polio/Rhinovirus Recombinant (PVSRIPO)
PVSRIPO will be delivered intratumorally by convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. A stereotactic biopsy will be performed prior to virus administration. Immediately following the stereotactically-guided tumor biopsy, a catheter will be implanted in the operating room at a site the same or different from that used for the biopsy using sterile techniques under general anesthesia. The entire volume of PVSRIPO to be delivered will be pre-loaded into a syringe by the investigational pharmacist and connected to the catheter under sterile conditions in the Pediatric Intensive Care Unit (PICU) just prior to beginning of infusion.
- Percentage of participants with unacceptable toxicity [ Time Frame: 14 days after treatment with PVSRIPO ]Percentage of participants with unacceptable toxicity during the 14-day period post-PVSRIPO treatment
- 24-month overall survival [ Time Frame: 24 months after administration of PVSRIPO ]The percentage of participants alive at 24 months after the administration of PVSRIPO. Overall survival is defined as the time from the date of administration of PVSRIPO until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.
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): NCT03043391
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Study Director:||Darell Bigner, MD, PhD||Istari Oncology, Inc.|
|Principal Investigator:||Daniel Landi, MD||Duke University|
|Principal Investigator:||Eric Thompson, MD||Duke University|