Randomized Phase II Trial of Autologous Vaccines Consisting of Adjuvant GM-CSF Plus Proliferating Tumor Cells Versus GM-CSF Plus Dendritic Cells Loaded With Proliferating Tumor Cells in Patients With Metastatic Melanoma (MAC-VAC)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of melanoma

- Regionally recurrent or distant metastatic disease

- Must have an established continuously proliferating cell line expanded to about 200
million cells that is free of stromal cells and contamination

- No active CNS metastases

- Prior treatment for brain metastases or spinal cord compression allowed

- No clear evidence of disease progression in the CNS

- No concurrent pharmacologic doses of corticosteroids

PATIENT CHARACTERISTICS:

- Karnofsky performance status (PS) 70-100% OR ECOG PS 0-1

- Platelet count > 100,000/mm³

- Hematocrit > 30%

- Creatinine < 2.0 mg/dL

- Bilirubin < 2.0 mg/dL

- Albumin > 3.0 mg/dL

- No significant hepatic or renal dysfunction

- No other invasive cancer within the past 5 years

- No active infection or other active medical condition that could be eminently life
threatening, including any of the following:

- Active blood clotting

- Bleeding diathesis

- No ongoing transfusion requirement

- No underlying cardiac disease associated with known myocardial dysfunction

- No unstable angina related to atherosclerotic cardiovascular disease

- No known autoimmune disease

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

- Prior surgery, radiotherapy, chemotherapy, biological therapy (including sargramostim
[GM-CSF]), or vaccine therapy allowed

- No concurrent anticancer therapy (e.g., hormone therapy for prostate or breast
cancer)

- No concurrent digoxin or other medications for the treatment of heart failure

- No concurrent immunosuppressive therapy