Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed melanoma with radiographic evidence of
prior or active involvement of the lung or pleura Measurable disease At least one lesion
with at least one dimension in diameter of at least 10 mm on CT scan or MRI No
non-measurable disease including the following: Bone lesions Leptomeningeal disease
Ascites Pleural or pericardial effusion Inflammatory breast disease Lymphangitis cutis or
pulmonis Unconfirmed abdominal masses not followed by imaging Cystic lesions

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/mm3 Platelet count
at least 75,000/mm3 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 Other: No uncontrolled infection Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic or
immunotherapy No other concurrent biologic or immunotherapy Chemotherapy: At least 4 weeks
since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) No concurrent
chemotherapy Endocrine therapy: At least 2 weeks since prior corticosteroids No concurrent
systemic glucocorticosteroids Radiotherapy: At least 2 weeks since prior radiotherapy No
concurrent radiotherapy Surgery: Not specified Other: No concurrent immunosuppressants