Immunotherapy Study for Metastatic Renal Cell Cancer

Exclusion Criteria

• •Age \<18-years-old.
• •Active CNS metastases or carcinomatous meningitis. Patients with CNS lesions that have been treated and who have no evidence of progression in the brain on CT/MRI for ≥1 month are eligible.
• •Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant.
• •Other malignancy within five years, except that the following may be eligible:
• •patients curatively treated for localized squamous or basal cell carcinoma of the skin or for carcinoma in situ of the uterine cervix (CIN) or breast,
• •Patients with a history of malignant tumor who have been disease free for at least five years and are not currently being treated.
• •History of an allogeneic solid organ transplant or bone marrow transplant, or current active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
• •Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever (temp \> 38.1°C), if deemed clinically significant by the treating physician.
• •Evidence of active autoimmune disease (e.g., systemic lupus erythematosis, rheumatoid arthritis, with the exception of vitiligo. Patients with a remote history of asthma or mild asthma are eligible.
• •Other serious medical conditions that may be expected to limit life expectancy to less than 1 year (e.g., liver cirrhosis).
• •Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).
• •Patients having previously undergone splenectomy.
• •Patients with known hepatitis or unstable liver disease, and/or positive serologies for Hepatitis B or C and HIV.
• •Patients with sickle-cell anemia or thalassemia major.
• •History of any one or more of the following cardiovascular conditions within the past 6 months:
• •* Cardiac angioplasty or stenting
• •* Myocardial infarction
• •* Unstable angina
• •* Coronary artery bypass graft surgery
• •* Symptomatic peripheral vascular disease
• •* History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure
• •* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
• •Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
• •Concurrent investigational therapy given to treat cancer or concurrent participation in another clinical trial involving anti-cancer investigational drug.
• •Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.