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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006483 |
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.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer Metastatic Cancer |
Biological: sargramostim |
Phase II |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable metastatic disease in the lung
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Arizona | |
CCOP - Scottsdale Oncology Program | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
United States, Iowa | |
Siouxland Hematology-Oncology | |
Sioux City, Iowa, United States, 51101-1733 | |
CCOP - Iowa Oncology Research Association | |
Des Moines, Iowa, United States, 50309-1016 | |
CCOP - Cedar Rapids Oncology Project | |
Cedar Rapids, Iowa, United States, 52403-1206 | |
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 | |
CCOP - Metro-Minnesota | |
Saint Louis Park, Minnesota, United States, 55416 | |
CentraCare Clinic | |
Saint Cloud, Minnesota, United States, 56303 | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Nebraska | |
CCOP - Missouri Valley Cancer Consortium | |
Omaha, Nebraska, United States, 68131 | |
United States, North Dakota | |
Altru Health Systems | |
Grand Forks, North Dakota, United States, 58201 | |
CCOP - Merit Care Hospital | |
Fargo, North Dakota, United States, 58122 | |
Quain & Ramstad Clinic, P.C. | |
Bismarck, North Dakota, United States, 58501 | |
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 | |
CCOP - Sioux Community Cancer Consortium | |
Sioux Falls, South Dakota, United States, 57105-1080 | |
Central Plains Clinic, Ltd. | |
Sioux Falls, South Dakota, United States, 57105 | |
Rapid City Regional Hospital | |
Rapid City, South Dakota, United States, 57709 | |
Canada, Saskatchewan | |
Allan Blair Cancer Centre | |
Regina, Saskatchewan, Canada, S4T 7T1 | |
Saskatchewan Cancer Agency | |
Regina, Saskatchewan, Canada, S4S 6X3 |
Study Chair: | Patrick A. Burch, MD | Mayo Clinic |
Study ID Numbers: | CDR0000068314, NCCTG-N9953 |
Study First Received: | November 6, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006483 History of Changes |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer recurrent renal cell cancer lung metastases |
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Recurrence Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Neoplasm Metastasis Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Urogenital Neoplasms Urologic Neoplasms Carcinoma Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Neoplasm Metastasis Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |