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NCT00672542 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy of Melanoma With Tumor Antigen RNA and Small Inhibitory RNA Transfected Autologous Dendritic Cells
A Phase 1 study of Metastatic Melanoma and Absence of CNS Metastases, sponsored by Scott Pruitt.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00672542: Completed Phase 1 study of Metastatic Melanoma and Absence of CNS Metastases, sponsored by Scott Pruitt.
NCT00672542 is a Phase 1 study of Metastatic Melanoma and Absence of CNS Metastases that has completed, run by Scott Pruitt. The registered enrollment target is 12 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00672542, a Phase 1 study of Metastatic Melanoma and Absence of CNS Metastases, has completed, sponsored by Scott Pruitt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Transfection with siRNA targeting the immunoproteasome alters proteasome-mediated antigen processing by the dendritic cell, generating TAA-derived peptides that we hypothesize, based on preclinical results, will induce enhanced anti-melanoma immune responses. This phase I study, open to subjects with metastatic melanoma, will assess the safety of vaccination with melanoma tumor associated antigen-encoding RNA-transfected mature dendritic cells derived from monocytes that have been either untreated, transfected with control siRNA, or transfected with siRNA targeting the inducible immunoproteasome beta subunits LMP2, LMP7, and MECL1. A combination of RNAs encoding melanoma tumor associated antigens MART-1, tyrosinase, gp100, and MAGE-3 will be utilized for dendritic cell transfection. The vaccine will be administered by intradermal injection in the extremities. Clinical and laboratory toxicities will be characterized for each study arm. As a secondary objective, this phase I study will also assess the anti-melanoma immune responses, as well as clinical responses, induced by vaccination with this dendritic cell-based product.
Conditions Studied
Interventions
- BIOLOGICAL Proteasome siRNA and tumor antigen RNA-transfected dendritic cells
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-01 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
What the finished NCT00672542 record still lists
NCT00672542 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 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Proteasome siRNA and tumor antigen RNA-transfected dendritic cells is the first listed.
NCT00672542 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00672542 about?
NCT00672542 is a clinical study titled "Immunotherapy of Melanoma With Tumor Antigen RNA and Small Inhibitory RNA Transfected Autologous Dendritic Cells". Transfection with siRNA targeting the immunoproteasome alters proteasome-mediated antigen processing by the dendritic cell, generating TAA-derived peptides that we hypothesize, based on preclinical results, will induce enhanced anti-melanoma immune responses. This phase I study, open to subjects wit...
What is the current status of trial NCT00672542?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2008-01. Estimated completion is 2013-07.
What conditions does trial NCT00672542 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Absence of CNS Metastases.
What interventions are being tested in trial NCT00672542?
The interventions under investigation include: Proteasome siRNA and tumor antigen RNA-transfected dendritic cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00672542?
This trial is sponsored by Scott Pruitt, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00672542 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00672542's enrollment target sits among peer trials
12 85th of 91 higher than 6 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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.
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