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Ph.1B Pediatric PVSRIPO (Glioma, Brain Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to make sure that the dose of PVSRIPO we have chosen is safe to give to children and young adults and to see if PVSRIPO will work against Grade III and IV brain cancer.

What is the Condition Being Studied?

Brain Cancer (World Health Organization [WHO] Grade III or IV)

Who Can Participate in the Study?

Children 12 to 18 years old or adults 19 to 21 years old who have been diagnosed with brain cancer (WHO Grade III or IV) that has progressed or recurred.

Age Group
Children

What is Involved?

If you or your child choose to join this study, you or your child 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 the following morning
-- If the biopsy is positive for Grade III or IV brain cancer, a catheter will be placed in the location of the biopsy
- Get an infusion of PVSRIPO, which is s 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 watched overnight in the hospital
- Be followed in the clinic by the study team for at least 1 year

Study Details

Full Title
Phase 1b study of Oncolytic Polio/Rhinovirus Recombinant Against Recurrent Malignant Glioma in Children
Principal Investigator
Pediatric Neurosurgeon
Protocol Number
IRB:PRO00071228
NCT:NCT03043391
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698