Vaccine Therapy in Treating Patients With Stage IV Melanoma

DISEASE CHARACTERISTICS:

• Histologically confirmed cutaneous melanoma*

  • Stage IV disease (i.e., distant metastasis)
  • Not curable by surgical resection
• NOTE: *Metastatic melanoma with an unknown primary tumor allowed provided ocular melanoma can be definitely excluded and origin from the skin is likely

• Unidimensionally or bidimensionally measurable disease by physical examination and/or noninvasive radiological procedures

  • At least 1 measurable metastasis that has not been previously excised or biopsied
• Failed ≥ 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy)
• At least 1 metastatic lesion surgically accessible* for excision or biopsy to obtain tumor material for RNA isolation** NOTE: *Surgically accessible metastatic lesion not required provided properly processed tumor material or isolated tumor RNA is available from a metastasis excised or biopsied within the past 6 months

NOTE: **Major surgery not allowed for the acquisition of metastatic material solely for RNA isolation

• No active CNS metastases by CT scan or MRI

  • Previously treated CNS metastases (e.g., by excision of a single metastasis, gamma knife radiosurgery, or stereotactic radiotherapy) allowed provided there is no evidence of active CNS metastasis by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• Karnofsky 60-100%

Life expectancy

• At least 4 months

Hematopoietic

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

Hepatic

• Bilirubin < 2.0 mg/dL
• Hepatitis B surface antigen negative
• Hepatitis C antibody negative

Renal

• Creatinine < 2.5 mg/dL

Cardiovascular

• No clinically significant heart disease

Pulmonary

• No respiratory disease

Immunologic

• HIV-1 or -2 negative
• Human T-cell lymphotropic virus type I negative
• No known hypersensitivity to dimethylsulfoxide
• No immunodeficiency disease
• No active systemic infection

• No active autoimmune disease (except vitiligo), including any of the following:

  • Lupus erythematosus
  • Scleroderma
  • Rheumatoid arthritis (i.e., rheumatoid factor-positive arthritis with current or recent flare)
  • Ankylosing spondylitis
  • Autoimmune thyroiditis or uveitis
  • Autoimmune hemolytic anemia
  • Immune thrombocytopenic purpura
  • Multiple sclerosis
  • Inflammatory bowel disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile female patients must use effective contraception during and for ≥ 4 weeks after completion of study treatment
• Willing to undergo excision or biopsy of metastasis
• Willing to be hospitalized for ≥ 24 hours after each vaccination
• Medical condition stable
• No contraindication to leukapheresis
• No organic brain syndrome
• No significant psychiatric abnormality that would preclude study participation
• No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No other major serious illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• More than 4 weeks since prior systemic immunotherapy
• No systemic immunotherapy during and for 2 weeks after completion of study treatment

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior systemic chemotherapy
• No systemic chemotherapy during and for 2 weeks after completion of study treatment

Endocrine therapy

• No systemic corticosteroids, including steroid-containing inhalers or chronic use of topical steroids over large areas of the body (if systemic effects are likely or obvious) during and for 2 weeks after completion of study treatment

Radiotherapy

• See Disease Characteristics
• More than 2 weeks since prior radiotherapy
• No prior radiotherapy to the spleen
• Concurrent palliative radiotherapy to selected metastases for pain or local complications (e.g., compression) allowed

Surgery

• See Disease Characteristics
• Recovered from prior surgery
• No prior splenectomy
• No prior organ allograft
• Concurrent palliative surgery to selected metastases for pain or local complications (e.g., compression) allowed

Other

• Concurrent palliative hyperthermic therapy to selected metastases for pain or local complications (e.g., compression) allowed
• No concurrent participation in any other clinical trial
• No other systemic immunosuppressive agents (e.g., azathioprine or cyclosporine) during and for 2 weeks after completion of study treatment
• No other investigational drugs or paramedical substances during and for 2 weeks after completion of study treatment