Trial for Vaccine Therapy With Dendritic Cells in Patients With Metastatic Malignant Melanoma

Exclusion Criteria

• •The patient suffers from an ocular- or mucous membrane melanoma
• •History of prior malignancy other than melanoma, except for curatively treated basal cell or squamous cell carcinoma of the skin and cervix cancer stage 1B or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
• •Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune systems. PI shall make the final determination regarding appropriateness of enrollment
• •Autoimmune disease currently being treated with systemic steroids Version no. 3, 18 June 2009 Page 17 of 50
• •Adverse reactions to vaccines such as anaphylaxis or other serious reactions
• •History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome
• •Positive for HIV, Hepatitis B and C and Syphilis (treponema pallidum)
• •Pregnancy or lactation
• •If the patient has received any prior anti-cancer treatment, including radiotherapy, chemotherapy immunotherapy and/or immunomodulating agents, this must have been stopped at least 4 weeks before first study treatment administration.
• •Chemotherapy, glucocorticosteroids or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination
• •No treatment with dacarbazine or temozolomide at any time prior to study entry
• •Any reason why, in the opinion of the investigator, the patient should not participate