Metastatic Cancer Clinical Trial
Official title:
A Phase II Study Of Aerosolized GM-CSF In The Treatment Of Metastatic Renal Cell Carcinoma To The Lung
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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