Evaluation of safty of personalized Colon Cancer Cell Vaccine

Intervention 1: Intervention group: Patients with colorectal cancer, stage 4 which receive chemotherapy and vaccine. Autologous vaccine will be injected in two periods. The first period consists of three consecutive doses: the first dose will be injected one week after diagnosis /surgery, the next two doses will be injected with a week interval. One week after the third injection, chemotherapy will begin. After the first period, chemotherapy begins and continues for six months. The second period of the vaccine starts one month after chemotherapy and includes three consecutive vaccine doses with a distance of one week. Chemotherapy begins and continues two weeks after the sixth injection. Ten million irradiated tumor cells with 10 million BCG organisms are injected intradermally in the first and second injectons. The third, fourth, fifth and sixth injections contain 10 million irradiated tumor cells. Intervention 2: Control group: Patients with colorectal cancer, stage 4 which receive Chemotherapy treatment 5 weeks after diagnosis /surgery.
Primary outcome(s): Investigation of tumor markers levels (CEA, CA19-9) and liver enzymes and no new tumor formation. Timepoint: 6 months after the last vaccination. Method of measurement: Measure the umor markers levels (CEA, CA19-9) and liver enzymes concentration via Elisa method, and assay the new tumor formation via colonoscopy.
Study Design: Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.