Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514215
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2007-08-08
Brief Title:
Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Percutaneous Cryotherapy and Aerosolized GM-CSF for Pulmonary Metastases and Primary Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
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 LTPTGF-β1 Tr cells as measured by flow cytometry or ELISPOT assay for TGF-β1-secreting cells
Secondary
Determine clinical response ie 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
Primary
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 LTPTGF-β1 Tr cells as measured by flow cytometry or ELISPOT assay for TGF-β1-secreting cells
Secondary
Determine clinical response ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-C-2795 | None | None | None |
| WSU-HIC-050304M1RF | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |