Vaccination of Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer With HLA-A1, -A2 and -B35 Restricted Survivin Peptides
As prognosis of advanced melanoma, pancreatic, colon and cervical cancer remains gloomy, new
therapeutic modalities have to be developed to improve the patient´s clinical outcome.
Immunotherapy, which targets tumor associated antigens of tumor cells or tumor stroma, is
currently an intensively investigated, novel therapeutic option. As survivin is expressed
both by neoplastic cells as well as by endothelial cells of the tumor vasculature, this
antigen is an intriguing target molecule. Spontaneous cytotoxic T-cell responses against
different survivin epitopes in cancer patients underline the relevance of survivin-directed
immunological trials. This study is comprised of a peptide vaccine with HLA-A1, -A2 and -B35
restricted survivin epitopes in Montanide ISA-51 for patients with stage IV melanoma,
advanced pancreatic, colon and cervical carcinoma. The vaccine is applicated as a deep
subcutaneous injection. Vaccination is administered for the first 2 months weekly,
afterwards every 4 weeks. Standard staging examinations are performed every three months.
Clinical, laboratory and immunological monitoring is done every month.Diagnostic
leucapheresis is performed before first vaccination and afterwards every 2 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Juergen C Becker, MD
Department of Dermatology, University of Wuerzburg, Germany