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NCT02275039 · ClinicalTrials.gov registry record · Phase 1
p53MVA Vaccine and Gemcitabine Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02275039: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT02275039 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02275039, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and recommended dose of the combination of p53MVA vaccine (modified vaccinia virus ankara vaccine expressing tumor protein p53 \[p53\]) and gemcitabine hydrochloride in treating patients with ovarian epithelial cancer that has come back. Vaccines made from inserting a laboratory-treated gene into a person's tumor cells may help the body build an effective immune response to kill tumor cells that express p53. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving modified vaccinia virus ankara vaccine expressing p53 together with gemcitabine hydrochloride may work better in treating patients with ovarian epithelial cancer.
Primary Outcome
The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be used to grade adverse events. To be evaluable for toxicity, a patient must have received one course of gemcitabine and modified vaccinia virus ankara vaccine expressing p53 or experienced a dose-limiting toxicity.
Interventions
- OTHER laboratory biomarker analysis
- DRUG gemcitabine hydrochloride
- BIOLOGICAL modified vaccinia virus ankara vaccine expressing p53
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-01 |
| Est. Completion | 2018-04-23 |
| Phase | Phase 1 |
What the finished NCT02275039 record still lists
NCT02275039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT02275039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02275039 about?
NCT02275039 is a clinical study titled "p53MVA Vaccine and Gemcitabine Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer". This phase I trial studies the side effects and recommended dose of the combination of p53MVA vaccine (modified vaccinia virus ankara vaccine expressing tumor protein p53 \[p53\]) and gemcitabine hydrochloride in treating patients with ovarian epithelial cancer that has come back. Vaccines made from...
What is the current status of trial NCT02275039?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-01. Estimated completion is 2018-04-23.
What interventions are being tested in trial NCT02275039?
The interventions under investigation include: laboratory biomarker analysis (OTHER), gemcitabine hydrochloride (DRUG), modified vaccinia virus ankara vaccine expressing p53 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02275039?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02275039's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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