Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis
Condition: Lung Cancer; Metastatic Cancer
MeSH terms: Lung Neoplasms
Intervention: Cryotherapy (PTC); Prednisone
Intervention description: CT-guided PTC with the intent to eradicate the entire tumor(s).; Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Intervention MeSH terms: Prednisone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: lung metastases; stage I non-small cell lung cancer

Summary:

      RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving cryotherapy before surgery
      may kill more tumor cells.

      PURPOSE: This phase I trial is studying how well cryotherapy works in treating patients with
      primary stage I non-small cell lung cancer or lung metastasis.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed (by percutaneous transthoracic needle biopsy
             or transbronchial biopsy) diagnosis of 1 the following:

               -  Non-small cell lung carcinoma

                    -  Stage I disease

                    -  Primary disease

                    -  No primary lung metastatic disease, satellite lesions of the chest,
                       mediastinal lymph nodes > 1.5 cm, hepatic or adrenal masses by the PET scan
                       or the CT scan

               -  Metastatic cancer to the lung

                    -  Must have a definitive cancer diagnosis with the primary tumor under local
                       control and no metastatic disease other than to the lung

                    -  Solitary or multiple (≤ 3) peripheral lung lesions

                    -  No chemotherapy since the new metastatic lesion appeared

          -  Measurable disease, defined as 1 lesion unidimensionally measured ≤ 3.0 cm by
             conventional CT scan techniques

          -  Must be registered with the Clinical Trials office at the Karmanos Cancer Center/Wayne
             State University

          -  Must be a candidate for a thoracotomy

          -  No evidence of cerebral disease or metastatic disease of the brain

        PATIENT CHARACTERISTICS:

          -  Neutrophil count > 1,500/mm^3

          -  Platelet count > 75,000/mm^3

          -  PT and PTT normal

          -  FEV_1 > 1.0 L/sec

          -  Diffusing capacity ≥ 30%

          -  Not pregnant or nursing

          -  No other uncontrolled or concurrent illnesses including, but not limited to, any of
             the following conditions:

               -  Active infection

               -  Heart failure

               -  Unstable angina

               -  Cardiac dysrhythmia

               -  Psychiatric illness or a social situation that would limit compliance with the
                  study requirements

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior radiation therapy or chemotherapy for these particular tumors

          -  No concurrent aspirin or other platelet-inhibiting drugs (e.g., coumadin or heparin)

          -  No other concurrent experimental studies