Vaccination With Autologous Dendritic Cells Pulsed With Onco-Peptides for Treatment of Patients With Metastatic Breast Cancer.A Phase I/II Study
HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and
telomerase peptides. 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. Scans and re-staging tests are performed at scheduled intervals
throughout the study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary aim of the study is to evaluate tolerability and safety of the treatment.
Inge Marie Svane, MD, PHD
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
Denmark: Danish Medicines Agency