Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
- Conditions
- Kidney CancerMetastatic Cancer
- Registration Number
- NCT00006483
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine the 4-month progression-free survival rate 4 months
- Secondary Outcome Measures
Name Time Method Determine the 4-month overall survival rate 4 months
Trial Locations
- Locations (24)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - 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 - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Scroll for more (14 remaining)CCOP - Scottsdale Oncology Program🇺🇸Scottsdale, Arizona, United States