Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells (DCVaccineMel)

Inclusion Criteria:

• Recurrent or metastatic melanoma as defined by stage IV disease (distant metastases), or any recurrent melanoma manifested by lymph node metastases or soft tissue nodules
• ECOG Performance status of 0-2
• Satisfactory medical condition for treatment in a phase I-II trial of anticancer therapy
• Age > 16 years
• Venous access for leukopheresis procedure to obtain peripheral blood lymphocytes to generate dendritic cells.
• Serum pregnancy test must be negative for women of childbearing potential.

Exclusion Criteria:

• Active central nervous system metastases
• Known autoimmune disease or disease process that involves the use of immunosuppressive therapy.
• Underlying cardiac disease associated with New York Heart Association class III or IV function, or unstable angina related to atherosclerotic cardiovascular disease.
• Ongoing transfusion requirements, no significant hepatic or renal dysfunction, creatinine < 2.0 mg/dl, bilirubin < 2.0 mg/dl, albumin > 3.0 mg/dl, hematocrit > 25, platelets > 100,000.
• Active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis.