Recruitment

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