Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
- Conditions
- Metastatic CancerMelanoma (Skin)
- Registration Number
- NCT00005610
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Median survival Up to 1.5 years Progression-free survival 2 months
- Secondary Outcome Measures
Name Time Method Quality of life Up to 1.5 years
Trial Locations
- Locations (18)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Scroll for more (8 remaining)CCOP - Scottsdale Oncology Program🇺🇸Scottsdale, Arizona, United States