Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed metastatic melanoma to the lung for which no known standard therapy exists
• •At least 1 unidimensionally measurable lesion
• •HLA-A2 positive (part A patients only)
• •Previously treated CNS metastases allowed provided there is no evidence of disease progression within the past 3 months
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •ECOG 0-2
• •Life expectancy:
• •At least 12 weeks
• •Hematopoietic:
• •Absolute neutrophil count at least 1,000/mm\^3
• •Platelet count at least 75,000/mm\^3
• •Hemoglobin at least 8.0 g/dL
• •Hepatic:
• •Bilirubin no greater than 2 times upper limit of normal (ULN)
• •AST no greater than 3 times ULN
• •Renal:
• •Creatinine no greater than 2.5 times ULN
• •Cardiovascular:
• •No New York Heart Association class III or IV heart disease
• •Pulmonary:
• •No pulmonary disease requiring concurrent active therapy (e.g., supplemental oxygen or bronchodilator)
• •FEV\_1 at least 65% of predicted and at least 1.5 L
• •Immunologic:
• •No known immunodeficiency state
• •No known autoimmune disease
• •No uncontrolled infection
• •Other:
• •No active psychotic disorder requiring pharmacotherapy
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •More than 2 weeks since prior biologic therapy
• •More than 2 weeks since prior immunotherapy
• •More than 4 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
• •No other concurrent biologic therapy or immunotherapy
• •No concurrent G-CSF
• •No concurrent GM-CSF other than study drug
• •Chemotherapy:
• •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• •No concurrent chemotherapy
• •Endocrine therapy:
• •More than 2 weeks since prior corticosteroids
• •No concurrent glucocorticosteroids
• •Radiotherapy:
• •More than 2 weeks since prior radiotherapy
• •No concurrent radiotherapy
• •Surgery:
• •Not specified
• •Other:
• •More than 7 days since prior parenteral antibiotics
• •No concurrent parenteral antibiotics
• •No concurrent immunosuppressive agents