NCT00005610

Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung

Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (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 help the body's immune system to kill cancer cells. Giving sargramostim in different ways may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of sargramostim given as a breathing treatment for treating patients who have melanoma that is metastatic to the lung.

Detailed description

OBJECTIVES: I. Determine the therapeutic effects of aerosolized sargramostim (GM-CSF) in terms of progression free survival at 2 months and median survival rate in patients with metastatic melanoma to the lung. II. Determine the immunomodulatory effects of this treatment regimen in this patient population. III. Assess the quality of life in terms of physical and personal concerns of these patients treated with this regimen. OUTLINE: Patients receive aerosolized sargramostim (GM-CSF) over 10-15 minutes twice daily for 7 days. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to course 5. Patients are followed every 2 months for at least 1.5 years.

Conditions

• Melanoma (Skin)
• Metastatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	sargramostim

Timeline

• Start date: 2000-09-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2004-02-12
• Last updated: 2016-07-13

Locations

18 sites across 1 country: United States