Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
Condition: Kidney Cancer; Lung Cancer; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lung Neoplasms; Neoplasm Metastasis; Kidney Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

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+,
           LTP(TGF-β1)+, Tr cells as measured by flow cytometry or ELISPOT assay for
           TGF-β1-secreting cells.

      Secondary

        -  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.
    

Intervention name(s): sargramostim; flow cytometry; immunoenzyme technique; biopsy; cryosurgery
Intervention type(s): Biological; Other; Other; Procedure; Procedure
Intervention description(s): 250 μg, inhaled, two times a day, on days 4-10 and days 36-42; Days 1 & 32; Days 1 & 32; CT guided biopsy on days 1 & 32; Days 1 and 32
Other intervention name(s): GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor); Leukine
Intervention MeSH terms: Molgramostim; Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 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