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NCT00458536 · ClinicalTrials.gov registry record · Phase 1
Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF
A Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT00458536: Completed Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
NCT00458536 is a Phase 1 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00458536, a Phase 1 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any side effects associated with this study vaccine. GM-CSF is similar to a substance in the body that stimulates the production of white blood cells. To create the study vaccine, cells will be removed from the participants tumor and fused with dendritic cells which are obtained from the participants blood. Dendritic cells are responsible for immune responses to "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.
Interventions
- BIOLOGICAL Dendritic Cell Tumor Fusion Vaccine
- DRUG Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2004-10 |
| Est. Completion | 2023-07 |
| Phase | Phase 1 |
What the finished NCT00458536 record still lists
NCT00458536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Dendritic Cell Tumor Fusion Vaccine is the first listed.
NCT00458536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00458536 about?
NCT00458536 is a clinical study titled "Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF". The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any side effects associated wit...
What is the current status of trial NCT00458536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2004-10. Estimated completion is 2023-07.
What interventions are being tested in trial NCT00458536?
The interventions under investigation include: Dendritic Cell Tumor Fusion Vaccine (BIOLOGICAL), Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) (DRUG).
Who is sponsoring clinical trial NCT00458536?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00458536's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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