Polyvalent Breast-Cancer-Vaccination with Antigen-loaded Dendritic Cells: Study-Design and GMP-Conformity of Vaccine-Preparation
S Kayser, A Marme, M Waidmann, I Gruber, J Huober, S Stevanovic, C Rentzsch, D Wallwiener, B Gückel · Zentralblatt für Gynäkologie · 2005 · Heft 10
Bibliografische Angaben
Zusammenfassung
Aims: First: Evaluation of toxicity under Dendritic-Cell (DC) dosis-escalation. Secondary: clin. response and induction of T-cell mediated immunity, quality of life; evaluation of feasibility. Methods: Study-design: Bicentric phaseI/II study. In vitro prepared autologous mature DCs are loaded with 14 tumorantigen-derived HLA-A*0201-restricted epitopes. A dosis-escalation will be undertaken in 3 groups with 9 patients each. All patients receive 8 vaccinations of the same dosis. Patients: HLA-A*0201+ breast cancer patients with low-risk metastases. DC-vaccination is offered additionally to standard-therapy-regimes…