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NCT01453361 · ClinicalTrials.gov registry record · Phase 2
Phase II FANG™ in Advanced Melanoma
A Phase 2 study, sponsored by Gradalis.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01453361 is a Phase 2 study that was terminated before completion, run by Gradalis. The registered enrollment target is 18 participants.
The verdict
NCT01453361, a Phase 2 study, was terminated before completion, sponsored by Gradalis.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to overcome limitations of immunostimulatory cancer vaccines, the investigators have designed a novel autologous vaccine to address inability to fully identify cancer associated antigens, antigen recognition by the immune system (i.e. antigen to immunogen), effector potency, and cancer-induced resistance. In an effort to overcome limitations of immunostimulatory cancer vaccines, the investigators designed a novel dual-modulatory autologous whole cell vaccine, Vigil™ (bi-shRNA furin and GMCSF Autologous Tumor Cell Vaccine), incorporating the rhGMCSF (recombinant human GMCSF) transgene and the bifunctional shRNAfurin (to block proprotein conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer associated antigens, 2) effect antigen recognition by the immune system (i.e. antigen to immunogen), 3) enhance effector potency, and 4) subvert endogenous cancer-induced immune resistance. The investigators have also completed the Phase I assessment of Vigil™ vaccine in 27 advanced solid tumor patients (1.0 x 10e7 or 2.5 x 10e7 cells/injection/month for a maximum of 12 vaccinations) who have not experienced any significant adverse effects following 131 vaccinations, including 4 patients with melanoma. Plasmid functionality, immune biomarker response, and preliminary evidence of anticancer activity have been observed. This is a Phase II study of intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations) in patients with stages IIIc and IV melanoma with biopsy accessible lesions to document blood and intratumoral immune responses and assess correlation with survival.
Interventions
- BIOLOGICAL Vigil™ Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-03-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01453361
The ClinicalTrials.gov registry entry for NCT01453361 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gradalis, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vigil™ Vaccine is the first listed.
NCT01453361 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01453361 about?
NCT01453361 is a clinical study titled "Phase II FANG™ in Advanced Melanoma". Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to overcome limitations of immunostimulatory cancer vaccines, the investigators have designed a novel autologous vaccine to ...
What is the current status of trial NCT01453361?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2011-10. Estimated completion is 2016-03-22.
What interventions are being tested in trial NCT01453361?
The interventions under investigation include: Vigil™ Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01453361?
This trial is sponsored by Gradalis, which has 13 total clinical trials registered on ClinicalTrials.gov.
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