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Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung Clinical research trials and Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung. Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung clinical trial. Participants frequently get the best healthcare available for their Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung  Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
For Condition: recurrent renal cell cancer,lung metastases,stage 4 renal cell cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: 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.
Details: OBJECTIVES: I. Determine the progression-free survival rate and overall survival rate in patients with metastatic renal cell carcinoma to the lung treated with aerosolized sargramostim (GM-CSF). II. Determine the toxicity of this regimen in these patients. III. Determine the immunomodulatory effects of this regimen in terms of natural killer cells cytotoxicity, and T cell, B cell, and dendritic cell activation markers. PROTOCOL OUTLINE: This is a multicenter study. Patients receive aerosolized sargramostim (GM-CSF) by nebulizer over 10-15 minutes twice daily for 7 days. Treatment repeats every 14 days for a total of 8 courses. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 21-48 patients will be accrued for this study within 7-20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic renal cell carcinoma not amenable to curable therapy (e.g., surgery) - Measurable metastatic disease in the lung; Measurable disease defined as at least one lesion greater than or equal to 20 mm with conventional techniques; Other sites of metastatic disease in addition to the lung allowed - No CNS metastases that requires treatment --Prior/Concurrent Therapy-- - Biologic therapy: At least 2 weeks since prior immunotherapy; At least 2 weeks since other prior biologic therapy - Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) - Endocrine therapy: At least 2 weeks since prior corticosteroids; No concurrent systemic glucocorticoids - Radiotherapy: At least 2 weeks since prior radiotherapy; No prior radiotherapy to more than 10% of total lung volume in the radiation field - Surgery: See Disease Characteristics - Other: At least 4 weeks since prior bronchodialators; No concurrent immunosuppressive agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,000/mm3; Platelet count at least 75,000/mm3; Hemoglobin greater than 8.0 g/dL - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); AST no greater than 3 times ULN - Renal: Creatinine no greater than 2.5 times ULN - Pulmonary: No hemoptysis of grade 3 or greater; No reactive airway disease on active therapy - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No uncontrolled infection; No other metastatic malignancy within the past 3 years except basal cell carcinoma of the skin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickBurch, Study Chair, North Central Cancer Treatment Group
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Saskatchewan Cancer Agency
Regina, Saskatchewan, S4S 6X3
Canada
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Central Plains Clinic, Ltd.
Sioux Falls, South Dakota, 57105
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
Quain & Ramstad Clinic, P.C.
Bismark, North Dakota, 58501
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Additional Information:
Study ID Numbers: CDR0000068314; NCCTG-N9953
Study Start Date: October 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006483
Other Recurrent Renal Cell Cancer Studies:
1. Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
2. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
3. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma
4. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
5. Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other Minnesota Clinical Trials
Other St. Louis Park Clinical Trials
Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
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