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NCT01169584 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors in Pediatric Patients
A Phase 1 study, sponsored by Jennerex Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01169584: Completed Phase 1 study, sponsored by Jennerex Biotherapeutics.
NCT01169584 is a Phase 1 study that has completed, run by Jennerex Biotherapeutics. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01169584, a Phase 1 study, has completed, sponsored by Jennerex Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase I, open-label, dose-escalation trial of JX-594 (Pexa-Vec) in pediatric patients with advanced/metastatic, unresectable solid tumors refractory to standard therapy and/or the patient does not tolerate standard therapies. Tumors are likely to include neuroblastoma, lymphoma, Wilms' tumor, rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcomas, and malignant peripheral nerve sheath tumors. Benign tumors are excluded. These tumor types were selected because evidence of biological activity was observed in cancer cells lines and ex vivo infected primary human tissue samples, specifically pediatric cancer types such as sarcomas and neuroblastomas.
Primary Outcome
Determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intratumoral (IT) injection in pediatric patients with advanced/metastatic, unresectable refractory solid tumors
Interventions
- DRUG Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01169584 record still lists
NCT01169584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) is the first listed.
NCT01169584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01169584 about?
NCT01169584 is a clinical study titled "Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors in Pediatric Patients". This is a Phase I, open-label, dose-escalation trial of JX-594 (Pexa-Vec) in pediatric patients with advanced/metastatic, unresectable solid tumors refractory to standard therapy and/or the patient does not tolerate standard therapies. Tumors are likely to include neuroblastoma, lymphoma, Wilms' tum...
What is the current status of trial NCT01169584?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2010-08. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01169584?
The interventions under investigation include: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) (DRUG).
Who is sponsoring clinical trial NCT01169584?
This trial is sponsored by Jennerex Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01169584's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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