Phase I/II Study of Vaccination With Antigen Loaded Dendritic Cells (DCs) in Hormone-Refractory Prostate Cancer

Inclusion Criteria

• •histologically or cytologically proven prostatic carcinoma
• •proven hormonal resistance: tumor progression after orchiectomy or during treatment with hormonal agents. Patients treated with antiandrogens, such as flutamide (Flucinom) or bicalutamide (Casodex), should have been discontinued the drug 6 weeks prior to the trial entry followed by no tumor response within this 6 weeks
• •not amenable to curative therapy
• •patients with measurable and non-measurable disease may be included. Bone lesions only are considered to be non-measurable
• •Previous radiotherapy is allowed if it has been stopped 4 weeks or more before the trial treatment and did not involve lesions used to evaluate activity of the trial drugs
• •one previous chemotherapy (including Estracyt) is allowed, but the chemotherapy should have been stopped at least 6 weeks before study entry
• •age \>18 years
• •performance status 0,1,2 (ECOG, Appendix I)
• •no concurrent therapy with steroids
• •no uncontrolled infections
• •live expectancy more than 3 months
• •Human leukocyte antigen (HLA)-Type has to be HLA\*A201
• •neutrophile count \>1500/microl and thrombocytes \>100 000/microl
• •creatinine \<1.5 of upper normal level
• •adequate liver function with bilirubin \<2 of upper normal level, alanine aminotransferase (ALAT) and aspartate transamionase (ASAT) \< 3 x upper normal level
• •absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• •before patient registration/randomization, informed consent must be given according to good clinical practice (GCP), and national/local regulations