Primary Outcome Measures:
- Primary aim of the study is to evaluate tolerability and safety of the treatment. [ Time Frame: weekly for the first four weeks, thereafter biweekly ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary aims: evaluation of treatment induced immune response and clinical response. [ Time Frame: after 8 and 16 weeks of treatment ] [ Designated as safety issue: No ]
Intervention Details:
Biological: tumor antigen loaded autologous dendritic cells
DC vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6). HLA-A2 positive patients are treated with survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate-pulsed dendritic cells id.From the 2nd vaccine, 2 MIU Interleukin-2 is administered sc on day 2-6.
Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. The dendritic cells are generated from leukapheresis products and frozen after antigen loading.
HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; survivin and telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by either intranodal or intradermal injection near the inguinal region. For adjuvant used IL-2 2 MIU sc. day 2-6 is used. Scans and re-staging tests are performed at scheduled intervals throughout the study.