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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00803569
The ClinicalTrials.gov registry entry for NCT00803569 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Ludwig Institute for Cancer Research, which has 30 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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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