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NCT00803569 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
A Phase 1 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 2
- Study locations
NCT00803569: Completed Phase 1 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by Ludwig Institute for Cancer Research.
NCT00803569 is a Phase 1 study of Ovarian Cancer and Fallopian Tube Cancer that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 13 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00803569, a Phase 1 study of Ovarian Cancer and Fallopian Tube Cancer, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 2
- Study locations
Study Summary
This was a Phase 1, non-randomized, open-label, multicenter study of the ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine administered with the granulocyte macrophage-colony stimulating factor (GM-CSF) sargramostim in patients with NY-ESO-1- or LAGE-1-positive epithelial ovarian, fallopian tube, or primary peritoneal cavity cancers who had completed standard therapy for primary or recurrent disease and would have normally entered a period of observation. The primary study objective was to determine the safety and tolerability of study vaccination, with secondary objectives including the determination of clinical and immunological responses.
Primary Outcome
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period.
Conditions Studied
Interventions
- BIOLOGICAL Sargramostim
- BIOLOGICAL ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine
Study Locations (2)
New York
- Roswell Park Cancer Institute - Buffalo
- NYU Cancer Institute at New York University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2008-11-14 |
| Est. Completion | 2011-01-24 |
| Phase | Phase 1 |
What the finished NCT00803569 record still lists
NCT00803569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which Sargramostim is the first listed.
NCT00803569 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00803569 about?
NCT00803569 is a clinical study titled "Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers". This was a Phase 1, non-randomized, open-label, multicenter study of the ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine administered with the granulocyte macrophage-colony stimulating factor (GM-CSF) sargramostim in patients with NY-ESO-1- or LAGE-1-positive epithelial ovarian, fallopian tube, or primary perit...
What is the current status of trial NCT00803569?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2008-11-14. Estimated completion is 2011-01-24.
What conditions does trial NCT00803569 study?
This clinical trial studies the following conditions: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cavity Cancer.
What interventions are being tested in trial NCT00803569?
The interventions under investigation include: Sargramostim (BIOLOGICAL), ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00803569?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00803569 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00803569's enrollment target sits among peer trials
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