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NCT01347034 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS)
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01347034: Completed Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01347034 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01347034, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if injection of the participant's our own immune related white blood cells (called dendritic cells) into their tumor will strengthen their immune system to fight against their cancer.
Primary Outcome
Investigate the ability of an intensified radiation therapy (RT) regimen (namely, conventional RT with a high-dose hypofractionated boost) and Dendritic Cell (DC) administration to induce an enhanced T lymphocyte immune response specific for STS-TAAs. Criteria for immune response evaluation: Individual patients were considered as responders to TAAs if at any time point the response in IFN-γ ELISPOT assay was found higher than 30 spots per 200,000 cells or in proliferation assay higher than 3000
Interventions
- PROCEDURE External Beam Radiation Therapy (RT)
- BIOLOGICAL Autologous Dendritic Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01347034 record still lists
NCT01347034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which External Beam Radiation Therapy (RT) is the first listed.
NCT01347034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01347034 about?
NCT01347034 is a clinical study titled "Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS)". The purpose of this study is to determine if injection of the participant's our own immune related white blood cells (called dendritic cells) into their tumor will strengthen their immune system to fight against their cancer.
What is the current status of trial NCT01347034?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-01. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01347034?
The interventions under investigation include: External Beam Radiation Therapy (RT) (PROCEDURE), Autologous Dendritic Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01347034?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01347034's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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