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NCT00112957 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
A Phase 2 study, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT00112957: Completed Phase 2 study, sponsored by Ludwig Institute for Cancer Research.
NCT00112957 is a Phase 2 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00112957, a Phase 2 study, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This was a Phase 2, single-center, open-label study of recombinant vaccinia-NY-ESO-1 (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) injections in patients who had a complete response to standard therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and whose tumors expressed NY-ESO-1 or LAGE-1 antigen. Study objectives were to evaluate maintenance of remission at 12 months, time to failure of vaccine therapy, cellular and humoral immunity and any correlation with time to failure, and safety.
Primary Outcome
Time to failure (TTF) was evaluated as the crude proportion of patients in remission at 1 year, calculated as: 100 x (number of patients in remission at 1 year)/(number of patients with known status at 1 year). The Kaplan-Meier cumulative estimate of the proportion of patients in remission at 1 year was also calculated.
Interventions
- BIOLOGICAL rV-NY-ESO-1 vaccine
- BIOLOGICAL rF-NY-ESO-1 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2004-12 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
What the finished NCT00112957 record still lists
NCT00112957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which rV-NY-ESO-1 vaccine is the first listed.
NCT00112957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00112957 about?
NCT00112957 is a clinical study titled "Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer". This was a Phase 2, single-center, open-label study of recombinant vaccinia-NY-ESO-1 (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) injections in patients who had a complete response to standard therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and whose t...
What is the current status of trial NCT00112957?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2004-12. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00112957?
The interventions under investigation include: rV-NY-ESO-1 vaccine (BIOLOGICAL), rF-NY-ESO-1 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00112957?
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 NCT00112957's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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