NCT00006483

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Kidney Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	sargramostim

Timeline

• Start date: 2000-10-01
• Primary completion: 2003-01-01
• Completion: 2013-01-01
• First posted: 2004-04-29
• Last updated: 2016-07-13

Locations

24 sites across 2 countries: United States, Canada