Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
NCT ID: NCT00006483
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2000-10-31
2013-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who have kidney cancer that has spread to the lung.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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aerosolized sargramostim
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.
sargramostim
Interventions
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sargramostim
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed metastatic renal cell carcinoma for which no known standard therapy that is potentially curative or capable of extending life expectancy exists (e.g., surgery)
* Measurable metastatic disease in the lung
* At least one unidimensionally measurable lesion at least 20 mm by conventional techniques
* No CNS metastases that require treatment
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/mm\^3
* Platelet count at least 75,000/mm\^3
* 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 skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 2 weeks since prior immunotherapy
* More than 2 weeks since other prior biologic therapy
Chemotherapy
* More than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
Endocrine therapy
* More than 2 weeks since prior corticosteroids
* No concurrent systemic glucocorticoids
Radiotherapy
* More than 2 weeks since prior radiotherapy
* No prior radiotherapy to more than 10% of total lung volume in the radiation field
Other
* At least 4 weeks since prior bronchodialators
* No concurrent immunosuppressive agents
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Svetomir Markovic, MD, PhD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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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
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Clinic
Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Altru Health Systems
Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Central Plains Clinic, Ltd.
Sioux Falls, South Dakota, United States
Saskatchewan Cancer Agency
Regina, Saskatchewan, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Countries
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Other Identifiers
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CDR0000068314
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N9953
Identifier Type: -
Identifier Source: org_study_id
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