Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Evaluate the histologic result of treating patients with primary stage I non-small cell lung cancer or lung metastasis after neoadjuvant percutaneous cryotherapy (PTC). Secondary Provide a qualitative assessment of the histology from the ablation and tumor margins, comparing histologic observations with imaging-enhancement patterns by CT or PET scan before and after PTC. OUTLINE: Patients undergo CT-guided percutaneous cryotherapy (PTC) over 2 hours. Approximately 3 weeks after completion of PTC, patients undergo thoracotomy consisting of lobectomy of the primary lung cancer or wedge resection with adequate margin for the metastatic lesion, and mediastinal lymph node dissection. Tissue samples from ablation and tumor margins are collected during thoracotomy and compared with imaging-enhanced patterns of CT or PET scans taken at baseline and after PTC. After completion of study therapy, patients are followed periodically for 6 months.

Official Title
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A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer

Conditions
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Lung Cancer, Metastatic Cancer

Intervention / Treatment
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* Procedure: Cryotherapy (PTC)
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisone & Cryotherapy<br>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 | Procedure: Cryotherapy (PTC)<br>* CT-guided PTC with the intent to eradicate the entire tumor(s).<br>Drug: Prednisone<br>* 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<br>* Other names: Sterapred;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With a Response (Complete Response and Partial Response) | Treatment success was defined as > 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p). | 3 weeks post-Percutaneous Cryotherapy (PTC) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With a Pathologic Response | Histology samples from anterior, posterior, superior, inferior, medial and lateral areas of the resected tumor will be compared to enhancement zones of the ablation margin for any residual cancer. | 6 months post-Percutaneous Cryotherapy (PTC) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung metastases, stage I non-small cell lung cancer