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

Inclusion Criteria

• •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