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Phase II of PVSRIPO for Glioma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to look at if PVSRIPO is safe and will work for patients diagnosed with Grade 4 glioma that has recurred or progressed.

What is the Condition Being Studied?

Brain Cancer (WHO [World Health Organization] Grade 4 Glioma)

Who Can Participate in the Study?

Adults who:
- Have been diagnosed with WHO Grade 4 glioma that progressed or recurred for the first or second time
- Have a tumor that meets size and location in brain requirements
- Are not pregnant or breastfeeding

Age Group
Adults

What is Involved?

If you choose to be in this study, you will:
- Get a polio immunization booster shot
- Have a blood test to make sure your body is protected against polio, both before and after the booster shot
- Be admitted to the hospital for a surgical biopsy of the tumor.
-- If the biopsy is positive for Grade 4 glioma, a catheter will be placed in the location of the biopsy.
- Get an infusion of PVSRIPO, which is a form of the live polio virus vaccine that has been changed by removing a piece of the virus and replacing it with a piece from a common cold virus.
-- The infusion is given through the catheter and takes about 6 and a half hours. The catheter is then removed.
- Be observed for at least a night in the hospital
- Are followed in the clinic by the study team for at least 1 year

Study Details

Full Title
A randomized Phase 2 study of Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) alone or in combination with lomustine in recurrent WHO grade IV malignant glioma patients
Principal Investigator
Protocol Number
IRB:PRO00077024
NCT:NCT02986178
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698