NCT01334047

Trial of Vaccine Therapy in Recurrent Platinum Sensitive Ovarian Cancer Patients

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Steinar Aamdal · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Epithelial Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	DC-006 vaccine	Vaccine is administered every 4 weeks during the first year. Only patients that show immunological response will continue vaccination every months during the 2nd and 3rd year.

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-04-12
• Last updated: 2021-02-26

Locations

1 site across 1 country: Norway