Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung

OBJECTIVES:

- Determine the 4-month progression-free survival rate and overall survival rate in
patients with metastatic renal cell carcinoma to the lung treated with aerosolized
sargramostim (GM-CSF).

- Determine the toxicity of this regimen in these patients.

- Determine the immunomodulatory effects of this regimen in terms of natural killer cells
cytotoxicity, and T-cell, B-cell, and dendritic cell activation markers.

OUTLINE: This is a multicenter study.

Patients receive aerosolized sargramostim (GM-CSF) by nebulizer over 10-15 minutes twice
daily on days 1-7 and 14-21. Treatment repeats every 28 days in the absence of disease
progression or unaceptable toxicity.

Patients are followed for disease progression and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 21-48 patients will be accrued for this study within 7-20
months.

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

Other

- At least 4 weeks since prior bronchodialators

- No concurrent immunosuppressive agents