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Trial of Bi-shRNA-furin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer
NCT01061840 · View on ClinicalTrials.gov ↗
Study Summary
Autologous Vigil™ vaccine expresses rhGMCSF and bi-shRNAfurin from the Vigil™ plasmid. The GMCSF protein is a potent stimulator of the immune system, recruiting immune effectors to the site of intradermal injection and promoting antigen presentation. The furin bifunctional shRNA blocks furin protein production at the post transcriptional and translational levels. This decrease in furin in turn decreases the conversion of the proforms TGFβ1 and TGFβ2 proteins. Also, reduced furin protein levels have a negative feedback inhibition on TGFβ1 and TGFβ2 gene expression, decreasing the levels of their mRNAs. The resulting decrease in TGFβ1 and TGFβ2 proteins reduces the local immunosuppression they cause and promotes tumor surface antigen and MHC protein display.
Conditions Studied
Interventions
- BIOLOGICAL Vigil™
Study Locations (4)
Florida
- Florida Cancer Specialists — West Palm Beach
New Hampshire
- Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center — Lebanon
Texas
- Mary Crowley Cancer Research Centers — Dallas
Washington
- Cancer Care Northwest — Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2009-12 |
| Est. Completion | 2019-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01061840
The ClinicalTrials.gov registry entry for NCT01061840 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gradalis, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention — of which Vigil™ is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01061840 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Florida, New Hampshire, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01061840 about?
NCT01061840 is a clinical study titled "Trial of Bi-shRNA-furin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer". Autologous Vigil™ vaccine expresses rhGMCSF and bi-shRNAfurin from the Vigil™ plasmid. The GMCSF protein is a potent stimulator of the immune system, recruiting immune effectors to the site of intradermal injection and promoting antigen presentation. The furin bifunctional shRNA blocks furin protein...
What is the current status of trial NCT01061840?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2009-12. Estimated completion is 2019-01.
What conditions does trial NCT01061840 study?
This clinical trial studies the following conditions: Non Small Cell Lung Cancer, Liver Cancer, Ewings Sarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01061840?
The interventions under investigation include: Vigil™ (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01061840?
This trial is sponsored by Gradalis, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01061840 being conducted?
This trial has 4 study locations across Florida, New Hampshire, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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