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About
RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving an injection of GM-CSF before cryotherapy and inhaling GM-CSF after cryotherapy may interfere with the growth of tumor cells and shrink the tumor. Giving cryotherapy together with GM-CSF may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cryotherapy together with GM-CSF works in treating patients with lung metastases or primary lung cancer.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo CT-guided core biopsy of a dominant lung mass and placement of at least 2 cryoprobes. Prior to initiating the freeze, patients receive an interstitial injection of sargramostim (GM-CSF) near the tumor. Patients then undergo percutaneous cryotherapy over 2 hours utilizing a freeze-thaw-freeze cycle. Beginning within 3 days of cryotherapy, patients receive aerosolized GM-CSF twice daily for 1 week. Beginning on day 32, patients may elect to undergo a second course of treatment as described above in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and tumor tissue collection at baseline and periodically during study for immunological correlative studies. Peripheral blood mononuclear cells isolated from blood samples are analyzed for antigen-specific CD4-positive or CD8-positive T-cell response by flow cytometry or by TGF-β1 ELISPOT assay to measure TGF-β1- secreting cells. Tumor cell lysates extracted from tumor samples are pulsed with autologous dendritic cells and analyzed by ELISPOT assay to measure T-cell reactivity in tumor specimens.
After completion of study therapy, patients are followed at 6 and 12 months.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Primary non-small cell lung cancer (NSCLC)
Any cancer with pulmonary metastatic disease (including renal cell cancer)
Must have 1-10 pulmonary or mediastinal masses meeting the following criteria:
At least 1 mass is appropriate for 2 sessions of core biopsy and cryotherapy with relatively easy access/low risk in nonoperative patients (or those refusing surgery)
The two dominant masses are defined as either the largest and/or those that may cause imminent morbidity from continued local progression, thereby potentially benefiting from thoracic cryotherapy alone
Optimal tumor size > 1.0 cm
Measurable disease, defined as tridimensional measurements of up to 6 different pulmonary or mediastinal masses ≥ 0.5 cm by CT scan
No active pleural effusion that could be related to respiratory infection or requires further work-up
No untreated and/or unstable brain metastases
PATIENT CHARACTERISTICS:
Karnofsky performance status 70-100%
Life expectancy ≥ 12 weeks
Granulocyte count ≥ 1,500/mm³
Platelet count ≥ 50,000/mm³
INR < 1.5 (i.e., normal PT/PTT)
Hemoglobin ≥ 8.0 g/dL
Bilirubin ≤ 2 times upper limit of normal (ULN)
AST ≤ 3 times ULN
Satisfactory pulmonary function test as determined by supervising oncologist, thoracic surgeon, or pulmonologist
Not pregnant or lactating
Negative pregnancy test
Fertile patients must use effective contraception
No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
No serious medical or psychiatric illnesses that would preclude informed consent or limit survival to < 12 wks
No uncontrollable cough or inability to lie flat
No New York Heart Association class III or IV heart disease
No known immunodeficiency state
No uncontrolled infection
No uncontrolled coagulopathy or bleeding diathesis
No advance directive that would prevent the investigator from treating the participant in the event of a complication occurring during or after the procedure
No medical contraindication or potential problem that would preclude protocol compliance
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
Masking
8 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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