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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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.
Oslo University Hospital- Norwegian Radium Hospital
Oslo, Norway
Frequency and severity of adverse events
Patients are coming every 4 weeks to the site during the 3 years vaccination period and every 6 months during the 5 years follow up period. Biochemistry and hematology results, vital signs and ECOG performance status will be measured at those timepoints during vaccination period.
Time frame: Up to 3 years
Determine immunological response to the vaccine (induction of specific T-cell response)
Time frame: 8, 12 weeks after start of vaccination and every 3 months thereafter
Determine time of disease progression and survival time.
Clinical response will be evaluated via: * measurement of CA-125 every 4 weeks * physical examination every 3rd months during vaccination * CT taken every 3rd months during vaccinaton and every 3-6 months during follow up.
Time frame: Every 4 weeks during vaccination and every 3-6 months during follow up
Treatment free interval
Start date of new antineoplastic therapy since discontinuation of the study will be recorded to capture information regarding treatment free interval.
Time frame: up to 5 years after vaccination
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