Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children

  • STATUS
    Recruiting
  • End date
    Mar 1, 2022
  • participants needed
    12
  • sponsor
    Istari Oncology, Inc.
Updated on 18 July 2021
platelet count
cancer
measurable disease
ependymoma
MRI
initial diagnosis
prothrombin
brain mri
metastasis
neutrophil count
thromboplastin
glioblastoma multiforme
astrocytoma
gliosarcoma
malignant glioma
oligodendroglioma
anaplastic astrocytoma
anaplastic oligodendroglioma
astrocytoma, anaplastic
oligoastrocytoma
anaplastic oligoastrocytoma
recurrent malignant glioma
recurrent tumor
oligodendroglioma, anaplastic
medulloblastoma
atypical teratoid/rhabdoid tumor
rhabdoid tumor
stereotactic biopsy
pleomorphic xanthoastrocytoma
brain mri with and without contrast

Summary

The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. The primary objective is to confirm the safety of the selected dose of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED) in children with recurrent WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma) or WHO Grade IV malignant glioma (glioblastoma, gliosarcoma). A secondary objective is to estimate overall survival (OS) in this population.

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 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.

Details
Condition Ependymoma, Medulloblastoma, Oligodendroglioma, Astrocytoma, Glioma, gliosarcoma, Glioblastoma Multiforme, High Grade Glioma, Anaplastic Oligoastrocytoma, Atypical Teratoid/Rhabdoid Tumor of Brain, Pleomorphic Xanthoastrocytoma of Brain, Embryonal Tumor of Brain, Atypical Teratoid/Rhabdoid Tumor of Brain, Gliomas, Atypical Teratoid/Rhabdoid Tumor of Brain, Atypical Teratoid/Rhabdoid Tumor of Brain, anaplastic astrocytoma, anaplastic oligodendroglioma, malignant glioma, glioblastoma, astrocytoma, anaplastic, oligodendroglioma, anaplastic, Atypical Teratoid/Rhabdoid Tumor of Brain, Atypical Teratoid/Rhabdoid Tumor of Brain, Atypical Teratoid/Rhabdoid Tumor of Brain, Atypical Teratoid/Rhabdoid Tumor of Brain, Atypical Teratoid/Rhabdoid Tumor of Brain
Treatment Polio/Rhinovirus Recombinant (PVSRIPO)
Clinical Study IdentifierNCT03043391
SponsorIstari Oncology, Inc.
Last Modified on18 July 2021

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note