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Brief Title: PVSRIPO in Recurrent Malignant Glioma
Official Title: A Multicenter Phase 2 Study of Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) in Recurrent WHO Grade IV Malignant Glioma Patients
Study ID: NCT02986178
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCSF Neurological Surgery, San Francisco, California, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Preston Robert Tisch Brain Tumor Center at Duke University, Durham, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Name: Dina Randazzo, DO
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR