Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma

Exclusion Criteria

• •Patients with active infections or oral temperature \> 38.2 C within 72 hours prior to planned leukapheresis; the procedure may be deferred
• •Patients with hematocrit (Hct) \< 30%, white blood cells (WBC) \< 2500/uL and platelets \< 50,000 immediately prior to leukapheresis; the procedure may be deferred
• •Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix
• •White blood cell count (WBC) \< 2000/uL
• •Hematocrit (Hct) \< 24% or hemoglobin (Hb) \< 8 g/dL
• •Absolute neutrophile count (ANC) \< 1000
• •Platelets \< 50,000
• •Creatinine \> 3.0 x upper limit normal (ULN)
• •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2.5 x ULN
• •Bilirubin \> 3 x ULN
• •Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception; women of childbearing potential with a positive pregnancy test within 3 days prior to entry
• •Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in one second (FEV1) \< 2.0 L or diffusion capacity of carbon monoxide (DLco) (corr for Hgb) \< 50% will be excluded
• •Significant cardiovascular abnormalities as defined by any one of the following:
• •* Congestive heart failure
• •* Clinically significant hypotension
• •* Symptoms of coronary artery disease
• •* Presence of cardiac arrhythmias on electrocardiogram (EKG) requiring drug therapy
• •* Ejection fraction \< 50 % (echocardiogram or multi gated acquisition \[MUGA\] scan)
• •Active and untreated central nervous system (CNS) metastasis (including metastasis identified during screening magnetic resonance imaging \[MRI\] or contrast CT)
• •Autoimmune disease: Patients with a history of Inflammatory Bowel Disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the Investigator to be unacceptable
• •Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
• •Positive screening tests for human immunodeficiency virus (HIV), hepatitis (Hep) B, and Hep C; if positive results are not indicative of true active or chronic infection, the patient can be treated
• •Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy
• •No prisoners or children will be enrolled on this study
• •Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose
• •Patients may not be on any other treatments for their cancer aside from those included in the protocol; patients may not undergo another form of treatment concurrently with this study