RNActive®-Derived Therapeutic Vaccine

Exclusion Criteria

• •Subjects who have received radiation therapy within 8 weeks of pretreatment evaluation. (There must be at least 12 weeks if prior therapy included 89-Strontium between any prior therapy and study entry.)
• •Subjects who have received chemotherapy, radiation therapy or biologic regimens within 8 weeks of pretreatment evaluation.
• •Subjects treated with any investigational agent within the past 30 days are excluded.
• •Subjects who have received active immunotherapy, such as Antigen Loaded Dendritic Cells, are excluded (Phase I only). In Phase IIa, Subjects who have received an active immunotherapy based on any of the antigens used in this study either as DNA, RNA or a protein/peptide-based vaccines are excluded. Subjects who have received any other active immunotherapy, such as Antigen Loaded Dendritic Cells, within 6 months prior to study entry are also excluded.
• •Subjects who have not recovered from radiation, chemotherapy, or immunotherapy toxicities.
• •Subjects with either previously irradiated or new CNS (central nervous system) metastases. (Pre-enrollment head CT is not required.)
• •Subjects with a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
• •Subjects with serious intercurrent chronic or acute illness such as pulmonary \[asthma or chronic obstructive pulmonary disease (COPD)\] 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.
• •Medical or psychological impediment to probable compliance with the protocol.
• •Concurrent second malignancy other than non-melanoma skin cancer, or controlled superficial bladder cancer. In the event of prior malignancies treated surgically, the subject must be considered NED (no evidence of disease) for a minimum of 3 years prior to enrollment.
• •Subjects on steroid therapy (or other immunosuppressive agents such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression. Subjects must have had 8 weeks of discontinuation of any steroid therapy prior to enrollment.
• •Presence of an active acute or chronic infection, including symptomatic urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology).
• •Subjects with penicillin allergies