Vaccine Biotherapy Of Cancer: Autologous Tumor Cells and Dendritic Cells as Active Specific Immunotherapy in Patients With Metastatic Melanoma

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.