Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
|ClinicalTrials.gov Identifier: NCT00514215|
Recruitment Status : Completed
First Posted : August 9, 2007
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer Lung Cancer Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific||Biological: sargramostim Other: flow cytometry Other: immunoenzyme technique Procedure: biopsy Procedure: cryosurgery||Phase 2|
- Determine whether percutaneous cryotherapy in combination with aerosolized sargramostim (GM-CSF) has any demonstrable immunologic effect in patients with pulmonary metastases or primary lung cancer.
- Determine whether any systemic immune response is detectable by the combination of cryotherapy as the antigen presentation source and GM-CSF as the immunologic adjuvant.
- Determine whether low morbidities will be maintained in patients treated with this regimen.
- Determine whether effective immunization is associated with a drop in CD4+, CD25+, LTP(TGF-β1)+, Tr cells as measured by flow cytometry or ELISPOT assay for TGF-β1-secreting cells.
- Determine clinical response (i.e., tumor control in the dominant masses undergoing cryotherapy or in other metastatic sites) as measured by CT criteria.
- Determine the toxicity of this regimen in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Percutaneous Cryotherapy and Aerosolized GM-CSF for Pulmonary Metastases and Primary Lung Cancer|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Experimental: Sargramostim, Flow Cytometry, Biopsy. Cryosurgery
Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32
250 μg, inhaled, two times a day, on days 4-10 and days 36-42
Other Names:Other: flow cytometry
Days 1 & 32Other: immunoenzyme technique
Days 1 & 32Procedure: biopsy
CT guided biopsy on days 1 & 32Procedure: cryosurgery
Days 1 and 32
- Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry [ Time Frame: Days 1 & 32 ]CT-guided biopsy & Peritumoral GM-CSF
- Clinical Response as Measured by CT Criteria [ Time Frame: Days 1 & 32 ]CT-guided biopsy
- Toxicity [ Time Frame: Days 11, 32, 43, & 63 ]CBC, sodium, potassium, BUN, serum creatinine, calcium, glucose, SGOT, Alk Phos, bilirubin, Electrolytes, Albumin (Alb), Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), Total bilirubin (TBIL), Direct bilirubin (Conjugated Bilirubin), Gamma glutamyl transpeptidase (GGT)
- Immune Function and Cancer-specific Response [ Time Frame: Days 1 & 32 ]CT-guided biopsy & Peritumoral GM-CSF
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514215
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Peter J. Littrup, MD||Barbara Ann Karmanos Cancer Institute|