Phase I/II Study of Vaccination With Antigen Loaded Dendritic Cells (DCs) in Patients With Inoperable Stage III and Stage IV Melanoma

Inclusion Criteria:

• Histologically confirmed melanoma
• Inoperable Stage III or Stage IV melanoma
• Tumor expression of Melan-A and/or NY-Eso-1 by immunohistochemistry
• Human leukocyte antigen (HLA)-A0201 positivity (flow cytometry and PCR)
• Life expectancy more than three months
• Full recovery from surgery
• Karnofsky scale performance status of 70% or more (App II)
• One prior chemo- or cytokine based therapy is allowed
• Age > 18 years
• No uncontrolled infections
• Neutrophile count >1500/ul and thrombocytes >100 000/ul
• Creatinine <1.5 of upper normal level
• Adequate liver function with bilirubin <2 of upper normal level, alanine aminotransferase (ALAT) and aspartate aminotransaminase (ASAT) < 3 x upper normal level
• Clinically significant (i.e. active) cardiovascular disease: Cardiovascular accident (CVA)/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure or serious cardiac arrythmia requiring medication
• 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, informed consent must be given according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), and national/local regulations

Exclusion Criteria:

• Presently clinically significant heart disease (NYHA Class III or IV)
• Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
• History of immunodeficiency disease or severe autoimmune disease
• Metastatic disease to the central nervous system
• HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) (test required) or any other severe uncontrolled infection
• Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry
• Concomitant treatment with steroids or antihistamine drugs. Topical or inhalational steroids are permitted
• Participation in any other clinical trial involving another investigational agent within 6 weeks prior to enrollment
• Pregnancy or lactation
• Women of childbearing potential not using a medically acceptable means of contraception
• Lack of availability of the patient for immunological and clinical follow-up assessment.
• Coagulation or bleeding disorders
• Rapidly progressing disease