- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor (TNF) agents) within 2 weeks prior to registration, or anticipated requirement for systemic immunosuppressive medications during the trial (Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enroled in the trial after discussion with CTC. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed. Low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed).