Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anaplastic Oligodendroglioma
- Anaplastic Astrocytoma
- Anaplastic Oligoastrocytoma
- Atypical Teratoid/Rhabdoid Tumor of Brain
- Embryonal Tumor of Brain
- Ependymoma
- Glioblastoma
- Gliosarcoma
- Malignant Glioma
- Medulloblastoma
- Pleomorphic Xanthoastrocytoma of Brain
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Phase Ib study to evaluate feasibility, safety, and preliminary evidence of efficacy of the optimal adult dose in a pediatric populationMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 21 years
- Gender
- Both males and females
Description
PVSRIPO will be delivered intratumorally by CED using an intracerebral catheter placed within the enhancing portion of the tumor. The population group are patients with recurrent WHO grade III or IV malignant glioma who are aged 12 through 21 years old. After a single dose of PVSRIPO, subjects will ...
PVSRIPO will be delivered intratumorally by CED using an intracerebral catheter placed within the enhancing portion of the tumor. The population group are patients with recurrent WHO grade III or IV malignant glioma who are aged 12 through 21 years old. After a single dose of PVSRIPO, subjects will return for periodic visits to monitor tumor status, adverse events, and changes in blood immune profiles. A maximum of 12 pediatric patients will be treated with PVSRIPO, and then carefully monitored for safety for at least a year after treatment.
Tracking Information
- NCT #
- NCT03043391
- Collaborators
- Solving Kids' Cancer
- The Andrew McDonough B+ Foundation
- Duke University
- Investigators
- Study Director: Darell Bigner, MD, PhD Istari Oncology, Inc. Principal Investigator: Daniel Landi, MD Duke University Principal Investigator: Eric Thompson, MD Duke University