Lung Cancer Clinical Trial

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

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.

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Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT00890617

Recruitment Status:

Completed

Sponsor:

Barbara Ann Karmanos Cancer Institute

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There is 1 Location for this study

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Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT00890617

Recruitment Status:

Completed

Sponsor:


Barbara Ann Karmanos Cancer Institute

How clear is this clinincal trial information?

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