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NCT01758458 · ClinicalTrials.gov registry record · Phase 1
Viral Oncoprotein Targeted Autologous T Cell Therapy for Merkel Cell Carcinoma
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01758458: Clinical Trial Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT01758458 is a Phase 1 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01758458, a Phase 1 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best way to give laboratory treated autologous T cells together with aldesleukin and to see how well it works in treating patients with merkel cell carcinoma that has spread from the primary site (place where it started) to other places in the body. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving cellular adoptive immunotherapy with aldesleukin may be a better treatment for metastatic merkel cell carcinoma.
Primary Outcome
The treatment will be considered to have an acceptable safety profile if the observed toxicity rate is consistent with a true rate that does not exceed 30%.
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Radiation Therapy
- BIOLOGICAL Aldesleukin
- BIOLOGICAL MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells
- BIOLOGICAL Recombinant Interferon Beta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
Why NCT01758458 stopped before completion
NCT01758458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01758458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01758458 about?
NCT01758458 is a clinical study titled "Viral Oncoprotein Targeted Autologous T Cell Therapy for Merkel Cell Carcinoma". This phase I/II trial studies the side effects and best way to give laboratory treated autologous T cells together with aldesleukin and to see how well it works in treating patients with merkel cell carcinoma that has spread from the primary site (place where it started) to other places in the body....
What is the current status of trial NCT01758458?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2013-02. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01758458?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Radiation Therapy (RADIATION), Aldesleukin (BIOLOGICAL), MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells (BIOLOGICAL), Recombinant Interferon Beta (BIOLOGICAL).
Who is sponsoring clinical trial NCT01758458?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01758458's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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