12. Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to Cycle 1, Day 1. Patients who have received acute and/or low-dose systemic immunosuppressant medications or anticipation of need for major surgery, a one-time dose of dexamethasone for nausea or chronic use of ≤ 10 mg/day of prednisone or dose-equivalent corticosteroid) may be enrolled in the study after discussion with and approval by the IND Office Medical Monitor. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed. Prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug.