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