Dose Finding Study of Aerosolized GM-CSF in the Treatment of Metastatic Melanoma 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