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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00514215 |
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 | Intervention | Phase |
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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 II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Percutaneous Cryotherapy and Aerosolized GM-CSF for Pulmonary Metastases and Primary Lung Cancer |
Estimated Enrollment: | 17 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Optimal tumor size > 1.0 cm
PATIENT CHARACTERISTICS:
No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
Sinai-Grace Hospital | Recruiting |
Detroit, Michigan, United States, 48235 | |
Contact: Peter J. Littrup 313-576-8758 |
Study Chair: | Peter J. Littrup, MD | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | Barbara Ann Karmanos Cancer Institute ( Peter J. Littrup ) |
Study ID Numbers: | CDR0000559667, WSU-C-2795, WSU-HIC-050304M1(R)F |
Study First Received: | August 8, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00514215 History of Changes |
Health Authority: | Unspecified |
lung metastases stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
stage IV non-small cell lung cancer recurrent non-small cell lung cancer recurrent renal cell cancer stage IV renal cell cancer unspecified adult solid tumor, protocol specific |
Thoracic Neoplasms Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Recurrence Carcinoma Renal Cancer Respiratory Tract Diseases Urologic Diseases |
Lung Neoplasms Kidney Neoplasms Lung Diseases Neoplasm Metastasis Carcinoma, Renal Cell Non-small Cell Lung Cancer Kidney Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Urogenital Neoplasms Urologic Neoplasms Carcinoma Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Respiratory Tract Diseases Urologic Diseases Kidney Neoplasms Lung Neoplasms Lung Diseases Carcinoma, Renal Cell Neoplasm Metastasis Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |