A Phase II Study Of Aerosolized GM-CSF In The Treatment Of Metastatic Renal Cell Carcinoma To The Lung

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic renal cell carcinoma for which no known standard
therapy that is potentially curative or capable of extending life expectancy exists
(e.g., surgery)

- Measurable metastatic disease in the lung

- At least one unidimensionally measurable lesion at least 20 mm by conventional
techniques

- No CNS metastases that require treatment

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 greater than 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

Pulmonary

- No hemoptysis of grade 3 or greater

- No reactive airway disease on active therapy

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled infection

- No other metastatic malignancy within the past 3 years except basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 2 weeks since prior immunotherapy

- More than 2 weeks since other prior biologic therapy

Chemotherapy

- More than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)

Endocrine therapy

- More than 2 weeks since prior corticosteroids

- No concurrent systemic glucocorticoids

Radiotherapy

- More than 2 weeks since prior radiotherapy

- No prior radiotherapy to more than 10% of total lung volume in the radiation field

Surgery

- See Disease Characteristics

Other

- At least 4 weeks since prior bronchodialators

- No concurrent immunosuppressive agents