Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

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.