Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

DISEASE CHARACTERISTICS:

• Histologically confirmed clearly progressive metastatic or unresectable melanoma
• Must be HLA-A2.1 positive
• Measurable disease

• No active brain metastases, leptomeningeal disease, or seizure disorder

  • More than 4 months since prior definitive therapy (surgery or radiotherapy) for brain metastases and must not have evidence of disease on brain CT scan or MRI
• No ascites or pleural effusions

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1 OR
• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

Renal:

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No congestive heart failure
• No symptoms of coronary artery disease
• No serious cardiac arrhythmias
• No evidence of prior myocardial infarction on EKG
• Normal cardiac stress test required for all patients over 40 years

Pulmonary:

• FEV_1 greater than 2.0 liters or at least 75% of predicted
• No chronic obstructive pulmonary disease

Other:

• HIV negative
• No significant systemic infection
• No contraindication to use of pressor agents
• No history of major psychiatric illness
• No other major illness that would significantly increase the risk of immunotherapy
• No other active malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ or stage I carcinoma of the cervix
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior interleukin-2
• At least 4 weeks since prior vaccine therapy or other cytokine therapy

Chemotherapy:

• One prior chemotherapy regimen allowed
• At least 4 weeks since prior chemotherapy (6 weeks for carmustine or lomustine) and recovered

Endocrine therapy:

• No concurrent steroids

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy to areas of measurable disease unless there has been clearly progressive disease in this site or there is measurable disease outside of areas of prior radiation
• At least 2 weeks since prior radiotherapy for local control or palliative therapy and recovered

Surgery:

• See Disease Characteristics
• Recovered from prior major surgery
• No prior organ allografts

Other:

• No antihypertensive therapy within 24 hours prior to interleukin-2