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NCT03072134 · ClinicalTrials.gov registry record · Phase 1
Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma
A Phase 1 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03072134: Completed Phase 1 study, sponsored by Northwestern University.
NCT03072134 is a Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03072134, a Phase 1 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem cell line in combination with radiation and chemotherapy is well-suited for evaluation in newly diagnosed malignant gliomas. The standard-of-care allows application of virotherapy as neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy without altering the standard treatment.
Primary Outcome
Using a 3+3 dose escalation design, three to six patients were to be enrolled per dose in each of the 3 cohorts. If no patients in the cohort experienced a dose-limiting toxicity (DLT), then the next cohort enrolled a minimum of 3 patients. If one of three patients experienced a DLT, then 3 more patients were evaluated at that dose level. If none of these three additional patients experienced a DLT, then dose escalation occurs, unless this is the highest dose, in which case dose escalation is st
Interventions
- BIOLOGICAL Neural stem cells loaded with an oncolytic adenovirus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-04-24 |
| Est. Completion | 2021-07-01 |
| Phase | Phase 1 |
What the finished NCT03072134 record still lists
NCT03072134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Neural stem cells loaded with an oncolytic adenovirus is the first listed.
NCT03072134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03072134 about?
NCT03072134 is a clinical study titled "Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma". Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm ...
What is the current status of trial NCT03072134?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-04-24. Estimated completion is 2021-07-01.
What interventions are being tested in trial NCT03072134?
The interventions under investigation include: Neural stem cells loaded with an oncolytic adenovirus (BIOLOGICAL).
Who is sponsoring clinical trial NCT03072134?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03072134's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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