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NCT01061840 · ClinicalTrials.gov registry record · Phase 1
Trial of Bi-shRNA-furin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer
A Phase 1 study of Non-Small Cell Lung Cancer and Liver Cancer, sponsored by Gradalis.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 4
- Study locations
NCT01061840 is a Phase 1 study of Non-Small Cell Lung Cancer and Liver Cancer that has completed, run by Gradalis. The registered enrollment target is 100 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT01061840, a Phase 1 study of Non-Small Cell Lung Cancer and Liver Cancer, has completed, sponsored by Gradalis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 4
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The listed sponsor is Gradalis, which has 13 total studies on file at ClinicalTrials.gov.
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.
NCT01061840 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, New Hampshire, Texas.
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, Ewing's Sarcoma.
What interventions are being tested in trial NCT01061840?
The interventions under investigation include: Vigil™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT01061840?
This trial is sponsored by Gradalis, which has 13 total clinical trials registered on ClinicalTrials.gov.
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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