Spots Global Cancer Trial Database for p53MVA Vaccine and Gemcitabine Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer

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Trial Identification

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

Official Title: A Phase I Study of a p53MVA Vaccine in Combination With Gemcitabine in Ovarian Cancer

Study ID: NCT02275039

Conditions

Recurrent Ovarian Epithelial Cancer

Recurrent Fallopian Tube Carcinoma

Recurrent Primary Peritoneal Carcinoma

Interventions

modified vaccinia virus ankara vaccine expressing p53

gemcitabine hydrochloride

laboratory biomarker analysis

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVES: I. To determine a recommended dose for the combination of a p53MVA vaccine and gemcitabine (gemcitabine hydrochloride) and if it is well-tolerated in patients with platinum resistant, p53 over expressing ovarian cancer. SECONDARY OBJECTIVES: I. To evaluate T cell immunity changes and clinical response. OUTLINE: Patients receive modified vaccinia virus ankara vaccine expressing p53 subcutaneously (SC) on day 15 and gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then continue to receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 12 months.