Prostatic cancer patients who have received curative surgery.
Conditions
Interventions
Product Name: Dendritic cell vaccine
Product Code: Dendritic cell vaccine
Pharmaceutical Form: Solution for injection
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Radical prostatectomy with negative resection margins. Preferably accessible tumor tissue with enough volume and quality for vaccine production (extraction of tumor mRNA). • Pathological stage pT2 - pT3b and Gleason score 7B-10, pN0, pN+ or pNx. • Must be ambulatory with an ECOG performance status 0 or 1. • Tumor cells detected in bone-marrow samples (micrometastatic disease). Patients with Gleason score 9-10 may also be included with negative bone-marrow aspiration. Bone-marrow aspirates and plasma for microRNA will be obtained before start of surgery. • Must be at least 18 years of age and less than 75 years. • PSA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous treatment with LHRH agonist. • Previous anti-androgen treatment (Casodex). • History of prior malignancy within the last 5 years, with the exception of curatively treated basal cell carcinoma. • Active infection requiring antibiotic therapy. • Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia. • Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions. • History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome. • Use of systemic glucocorticoids. • Negative testing for HIV, Hepatitis B and C • Any reason why, in the opinion of the investigator, the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and toxicity of vaccination with DCs transfected with h-TERT mRNA, survivin mRNA and autologous tumor cell mRNA andlymphnodepletion treatment in patients with prostatic cancer. Time to treatment failure defined by two different measurement of PSA levels >0.5 with minimum of 4 weeks interval. At this time the patients will be referred to standard radiation therapy.;Secondary Objective: Evaluation of immunological responses, time to disease progression and survival time. Safety and toxicity of vaccination with DCs transfected with mRNA for hTERT and survivin and autologous tumor mRNA from patients following curative surgery. Determine immunological response to the vaccine (induction of specific T-cell response) and time of disease progession and survival time. Monitor minimal residual disease in bone marrow and blood and compare results with immunological responses. ;Primary end point(s): The primary end-point of this study is: Time to PSA levels >0.5 with minimum 4 weeks interval. The secondary end-points of this study are: Safety and toxicity of the vaccination with mRNA transfected DCs, especially grade 3/4 adverse events assessed by reference to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE). Biochemistry, hematology, vital signs and ECOG performance status will also be assessed. Evaluation of immunological responses in terms of SI = 2 or delta ? = 10.000 measured by the 3H-thymidine proliferation test | — |
Countries
Norway
Outcome results
None listed