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NCT03043391 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
A Phase 1 study, sponsored by Istari Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03043391: Completed Phase 1 study, sponsored by Istari Oncology.
NCT03043391 is a Phase 1 study that has completed, run by Istari Oncology. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03043391, a Phase 1 study, has completed, sponsored by Istari Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
Percentage of participants with unacceptable toxicity during the 14-day period post-PVSRIPO treatment
Interventions
- BIOLOGICAL Polio/Rhinovirus Recombinant (PVSRIPO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-11-07 |
| Est. Completion | 2022-03-23 |
| Phase | Phase 1 |
What the finished NCT03043391 record still lists
NCT03043391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Polio/Rhinovirus Recombinant (PVSRIPO) is the first listed.
NCT03043391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03043391 about?
NCT03043391 is a clinical study titled "Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children". 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...
What is the current status of trial NCT03043391?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2017-11-07. Estimated completion is 2022-03-23.
What interventions are being tested in trial NCT03043391?
The interventions under investigation include: Polio/Rhinovirus Recombinant (PVSRIPO) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03043391?
This trial is sponsored by Istari Oncology, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03043391's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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