A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA

The patient is receiving concurrent chemotherapy, radiation therapy, or immunotherapy. There must be at least 4 weeks (12 weeks if prior therapy included 89-Strontium) between any prior therapy and study entry. Patients must have recovered from all acute toxicities from prior treatment.

The patient has previously irradiated or new CNS (central nervous system) metastases. (Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms.)

The patient has a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.

The patient has a serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.

The patient has a medical or psychological impediment to probable compliance with the protocol.

The patient has a concurrent second malignancy other than non-melanoma skin cancer, or controlled superficial bladder cancer.

The patient has an active acute or chronic infection, including symptomatic urinary tract infection, HIV, or viral hepatitis.

The patient is receiving oral or steroid therapy (or other immunosuppressive agents such as azathioprine or cyclosporine A). There must be 6 weeks between discontinuation of any steroid therapy and study enrollment.

The patient has inadequate peripheral vein access to perform leukapheresis.

What this study is about