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.
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Up to 3 years
Yes
Steinar Aamdal, M.D PhD Prof
Principal Investigator
Oslo University Hospital - Norwegian Radium Hospital
Norway: Norwegian Medicines Agency
DC-006
NCT01334047
April 2011
April 2022
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