drugset / Trial / NCT02275039

p53MVA Vaccine and Gemcitabine Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer

NCT02275039 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-01
Primary completion
2018-04-23
Completion
2018-04-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule — Intravenous
Subject MVA-p53 vaccine Vaccine — Subcutaneous