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NCT00199849 · ClinicalTrials.gov registry record · Phase 1
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00199849: Completed Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
NCT00199849 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. 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
NCT00199849, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
To evaluate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by particle-mediated epidermal delivery (PMED) in patients with tumor types known to express NY-ESO-1 or LAGE-1.
Primary Outcome
All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003). DLT was defined as * ≥ Grade 2 autoimmune phenomena * Asymptomatic bronchospasm or generalized urticaria * Grade ≥ non hematological toxicities (including injection site reactions) * Grade ≥ 3 hematological toxicities A dose-limiting adverse event must be definitely, probably, or possibly related to the administration of the investigational age
Interventions
- BIOLOGICAL NY-ESO-1 Plasmid DNA Cancer Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2004-09-27 |
| Est. Completion | 2007-09 |
| Phase | Phase 1 |
What the finished NCT00199849 record still lists
NCT00199849 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 1 intervention - of which NY-ESO-1 Plasmid DNA Cancer Vaccine is the first listed.
NCT00199849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00199849 about?
NCT00199849 is a clinical study titled "NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine". To evaluate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by particle-mediated epidermal delivery (PMED) in patients with tumor types known to express NY-ESO-1 or LAGE-1.
What is the current status of trial NCT00199849?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2004-09-27. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00199849?
The interventions under investigation include: NY-ESO-1 Plasmid DNA Cancer Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00199849?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00199849'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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