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

Study Overview
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Brief Summary
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RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may be an effective treatment for patients with kidney cancer that has spread to the lung. PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who have kidney cancer that has spread to the lung.

Detailed Description
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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.

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

Conditions
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Kidney Cancer, Metastatic Cancer

Intervention / Treatment
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* Biological: sargramostim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aerosolized sargramostim<br>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. | Biological: sargramostim<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the 4-month progression-free survival rate |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the 4-month overall survival rate |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, recurrent renal cell cancer, lung metastases