Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma

DISEASE CHARACTERISTICS:

• Histologically confirmed cutaneous* melanoma

  • Stage IV
• Incurable by surgical resection
• Progressive disease after at least 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy)
• Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or noninvasive radiological procedures

• No active CNS metastases by CT scan or MRI

  • Previously treated (e.g., excision of a single metastasis) CNS metastases are allowed provided there are no signs of active CNS metastases NOTE: *Metastatic melanoma with unidentified primary tumor allowed provided an ocular melanoma can be definitely excluded and origin from the skin is likely

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• At least 4 months

Hematopoietic

• WBC greater than 2,500/mm^3
• Neutrophil count greater than 1,000/mm^3
• Lymphocyte count greater than 700/mm^3
• Platelet count greater than 75,000/mm^3
• Hemoglobin greater than 9 g/dL
• No bleeding disorder

Hepatic

• Bilirubin less than 2.0 mg/dL
• No evidence of hepatitis B or C infection

Renal

• Creatinine less than 2.5 mg/dL

Cardiovascular

• No clinically significant heart disease

Pulmonary

• No respiratory disease

Immunologic

• HIV-1 and HIV-2 negative
• HTLV-1 negative
• No active systemic infection
• No immunodeficiency disease

• No active autoimmune disease (e.g., lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, or inflammatory bowel disease)

  • Vitiligo allowed

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 4 weeks after study participation
• Stable medical condition
• No other major serious illness
• No contraindication to leukapheresis
• No organic brain syndrome or significant psychiatric abnormality that would preclude study participation or follow-up
• No other active malignant neoplasm

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior immunotherapy
• No other concurrent immunotherapy during and for 2 weeks after study participation

Chemotherapy

• More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas [e.g., fotemustine])
• No concurrent chemotherapy during and for 2 weeks after study participation

Endocrine therapy

• No concurrent corticosteroids during and for 2 weeks after study participation

Radiotherapy

• More than 2 weeks since prior radiotherapy
• No prior radiotherapy to the spleen
• Concurrent palliative radiotherapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed

Surgery

• Recovered from prior surgery
• No prior splenectomy
• No prior organ allografts

• Concurrent surgical therapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed

  • Selected accessible metastases may be removed for tumor infiltrating lymphocyte assay or other immunomonitoring investigations (e.g., expression of tumor antigens and HLA molecules)

Other

• No other concurrent investigational drug or paramedical substance during and for 2 weeks after study participation
• No concurrent participation in another clinical trial
• Concurrent palliative medication allowed (e.g., acetaminophen, indomethacin, or opiates)