Evaluation of p53peptide-pulsed Dendritic Cells in Combination With an Aromatase Inhibitor as a Treatment for Patients With Breast Cancer With Disease Recurrence After Adjuvant or First Line Endocrine Therapy.
Only patients who have tumors > 5 % positive for p53 by IHC can be referred to this
treatment. All patients will receive standard dosage of AI +/- p53-DC vaccination. Patients
who express HLA-A2 will also receive DC vaccination. Patients that do not express HLA-A2
will receive only AI and be regarded as controls.
The vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval
(q1w x 4 → q2w x 6) with p53 peptide-pulsed dendritic cells, followed by monthly injections
until progression; proleukin and Zadaxin are used as vaccine adjuvants.
Defined procedures are employed for generation of autologous dendritic cells for clinical
application in a classified laboratory. Unmobilized leukapheresis will be used for isolation
of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by
cytokine stimulation and loaded with p53 peptides. Frozen preparations of dendritic cells
will be prepared using automated cryopreservation.Each patient will receive a minimum of
5x10^6 dendritic cells per treatment supplemented with interleukin-2 6 MIU/m² sc per vaccine
and 1.6 mg Thymosin 1 alpha sc x 2/week.
Toxicity including autoimmunity will be evaluated using the common Toxicity Criteria (CTC).
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine time to progression
after 8 and 16 weeks
Inge Marie Svane, prof MD
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev; Denmark
Denmark: Danish Medicines Agency