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NCT00313508 · ClinicalTrials.gov registry record · Phase 1
Dendritic Cell Vaccination During Lymphoid Reconstruction
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00313508: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00313508 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00313508, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a randomized, controlled, multicenter, dose-escalation study of fludarabine. Patients are randomized to 1 of 2 treatment arms. The purpose of this study is to find out what side effects are caused in this study and whether Fludarabine with the dendritic cell vaccine (DC vaccine) can increase the ability of the immune system to recognize melanoma.
Primary Outcome
Overall Survival is defined as the time from first day of treatment to time of death due to any cause. If a patient is still alive, survival time is censored at the time of last follow-up.
Interventions
- DRUG Fludarabine
- BIOLOGICAL Autologous Dendritic Cells (DC)
- BIOLOGICAL Autologous Lymphocyte Infusion (ALI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2006-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT00313508 record still lists
NCT00313508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Fludarabine is the first listed.
NCT00313508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00313508 about?
NCT00313508 is a clinical study titled "Dendritic Cell Vaccination During Lymphoid Reconstruction". This is a randomized, controlled, multicenter, dose-escalation study of fludarabine. Patients are randomized to 1 of 2 treatment arms. The purpose of this study is to find out what side effects are caused in this study and whether Fludarabine with the dendritic cell vaccine (DC vaccine) can increas...
What is the current status of trial NCT00313508?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2006-02. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00313508?
The interventions under investigation include: Fludarabine (DRUG), Autologous Dendritic Cells (DC) (BIOLOGICAL), Autologous Lymphocyte Infusion (ALI) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00313508?
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 NCT00313508's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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