Trial of Vaccine Therapy in Recurrent Platinum Sensitive Ovarian Cancer Patients
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.
Recurrent Epithelial Ovarian Cancer
Biological: DC-006 vaccine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Frequency and severity of adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
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.
- 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 ] [ Designated as safety issue: No ]
- Determine time of disease progression and survival time. [ Time Frame: Every 4 weeks during vaccination and every 3-6 months during follow up ] [ Designated as safety issue: No ]
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.
- Treatment free interval [ Time Frame: up to 5 years after vaccination ] [ Designated as safety issue: No ]Start date of new antineoplastic therapy since discontinuation of the study will be recorded to capture information regarding treatment free interval.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||April 2022|
|Estimated Primary Completion Date:||April 2022 (Final data collection date for primary outcome measure)|
Experimental: DC vaccine
Dendritic cells loaded with amplified ovarian cancer stem cell mRNA, hTERT and Survivin.
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.
Other Name: Dendritic cell vaccine
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334047
|Oslo University Hospital- Norwegian Radium Hospital||Recruiting|
|Oslo, Norway, 0424|
|Contact: Steinar Aamdal, MD Phd Prof +4722934000 firstname.lastname@example.org|
|Sub-Investigator: Janne Kærn, Dr.med|
|Sub-Investigator: Thea E Hetland, MD|
|Principal Investigator:||Steinar Aamdal, M.D PhD Prof||Oslo University Hospital - Norwegian Radium Hospital|