Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
Recruitment status was Active, not recruiting
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study Of Aerosolized GM-CSF In The Treatment Of Metastatic Renal Cell Carcinoma To The Lung|
|Study Start Date:||October 2000|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006483
|United States, Arizona|
|CCOP - Scottsdale Oncology Program|
|Scottsdale, Arizona, United States, 85259-5404|
|United States, Illinois|
|CCOP - Illinois Oncology Research Association|
|Peoria, Illinois, United States, 61602|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Iowa|
|CCOP - Cedar Rapids Oncology Project|
|Cedar Rapids, Iowa, United States, 52403-1206|
|CCOP - Iowa Oncology Research Association|
|Des Moines, Iowa, United States, 50309-1016|
|Sioux City, Iowa, United States, 51101-1733|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Louisiana|
|CCOP - Ochsner|
|New Orleans, Louisiana, United States, 70121|
|United States, Michigan|
|CCOP - Ann Arbor Regional|
|Ann Arbor, Michigan, United States, 48106|
|United States, Minnesota|
|CCOP - Duluth|
|Duluth, Minnesota, United States, 55805|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Saint Cloud, Minnesota, United States, 56303|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Nebraska|
|CCOP - Missouri Valley Cancer Consortium|
|Omaha, Nebraska, United States, 68131|
|United States, North Dakota|
|Quain & Ramstad Clinic, P.C.|
|Bismarck, North Dakota, United States, 58501|
|CCOP - Merit Care Hospital|
|Fargo, North Dakota, United States, 58122|
|Altru Health Systems|
|Grand Forks, North Dakota, United States, 58201|
|United States, Ohio|
|CCOP - Toledo Community Hospital Oncology Program|
|Toledo, Ohio, United States, 43623-3456|
|United States, Pennsylvania|
|CCOP - Geisinger Clinic and Medical Center|
|Danville, Pennsylvania, United States, 17822-2001|
|United States, South Dakota|
|Rapid City Regional Hospital|
|Rapid City, South Dakota, United States, 57709|
|Central Plains Clinic, Ltd.|
|Sioux Falls, South Dakota, United States, 57105|
|CCOP - Sioux Community Cancer Consortium|
|Sioux Falls, South Dakota, United States, 57105-1080|
|Saskatchewan Cancer Agency|
|Regina, Saskatchewan, Canada, S4S 6X3|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||Svetomir Markovic, MD, PhD||Mayo Clinic|