Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma

Exclusion Criteria

• •Patients whose primary site of melanoma is ocular.
• •Are undergoing or have undergone in the past 4 weeks any systemic treatment for melanoma.
• •Are undergoing or have undergone in the past 2 weeks any surgery or focal radiation therapy.
• •Have active systemic infections, coagulation disorders (including therapeutic anticoagulation), or other major medical or psychiatric illnesses.
• •Are known to be positive for hepatitis B surface antigen, anti-Hepatitis C Virus or anti-Human Immunodeficiency Virus (HIV) antibody (because of possible immune effects of these conditions).
• •Documented history of autoimmune disease, for example, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis.
• •Any form of primary or secondary immunodeficiency. This would include hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome, or acquired immune deficiencies such as following bone marrow transplantation.
• •Requirement for systemic steroid therapy or immunosuppressive therapy.
• •Have received any type of cancer immunotherapy, including but not limited to interleukin-2, interferon alfa or melanoma vaccines.
• •Have been diagnosed with another invasive cancer within the past 3 years.
• •Radiographic evidence of melanoma recurrence.
• •Pregnant or lactating women.
• •Known or suspected hypersensitivity to GM-CSF, pentastarch, hetastarch, corn, Dimethyl sulfoxide, fetal bovine serum or trypsin (porcine origin).