Trial of Vaccine Therapy in Recurrent Platinum Sensitive Ovarian Cancer Patients

Recurrent Epithelial Ovarian Cancer Clinical Trial

Official title: Phase I/II Trial of Vaccine Therapy in Recurrent Platinum Sensitive Epithelial Ovarian Cancer Patients Using Autologous Dendritic Cells Loaded With Amplified Ovarian Cancer Stem Cell mRNA, hTERT and Survivin.

Status Terminated

Clinical Trial Summary

In this study the investigators will include patients with relapsed epithelial ovarian cancer. In spite of increased rates of complete response to initial chemotherapy, most patients with advanced ovarian cancer relapse and succumb to progressive disease. Immunotherapy may have potential for consolidation therapy. Dendritic cell vaccine is well toleranted in previous studies, with minor side effects and no serious adverse events registrated In this study, patients will receive DC-vaccine therapy after response to platinum treatment at relapse. The investigtors include patients in good clinical condition with no severe symptoms of the disease. If patients relapse during vaccine treatment, they will be discontinued from the study.

The investigators have included hTERT- and survivin mRNA in addition to amplified cancer stem cell mRNA in the vaccine.

Clinical Trial Description

Study Period:

• Estimated date of first patient enrolled: First quarter of 2011

• Anticipated recruitment period: 3 years

• Estimated date of last patient completed: First quarter of 2017, follow up to 2022.

Treatment duration:

Patients will receive intradermal immunization once a week for 4 weeks followed by monthly "vaccine boost" during the first year. Patients that show immunological response will continue with vaccination every month the second and third year or as long as there is vaccine available. The patients will have follow up for 5 years or until progression of disease as evaluated by the investigator. ;

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Recurrent Epithelial Ovarian Cancer

• NCT number: NCT01334047
• Study type: Interventional
• Source: Oslo University Hospital
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 2011
• Completion date: August 2013