Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed malignant pulmonary neoplasm

- New lung lesion(s) with definitive clinical and imaging features of primary or
metastatic disease allowed

- Imaging findings compatible with localized treatment failure after prior
cryotherapy allowed

- Malignant pleural effusion allowed provided it is associated with a distinct
measurable pulmonary mass amenable to cryotherapy

- Metastatic disease must meet all of the following criteria:

- Primary tumors have been resected or have been deemed controlled by other
therapies

- No other widespread metastases evident (e.g., multiple hepatic or brain
metastases)

- Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach

- No more than 5 targeted masses for study therapy

- Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1
cm, but < 10 cm in average diameter

- Unresectable disease by surgical consultation OR patient refused surgical options

- Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm
increments with available soft tissue and mediastinal windows to assess size and
extent of all thoracic tumors

- PET scan required within the past 6 months noting the correlation with the above
CT locations, if not already obtained by a combined PET/CT scanner

PATIENT CHARACTERISTICS:

- Karnofsky performance status (PS) > 60-100% OR WHO/ECOG/Zubrod PS 0-2

- FEV_1 > 30% of predicted

- DLCO > 40% of predicted

- Platelet count ≥ 70,000/mm^3

- INR < 1.5

- No uncontrolled coagulopathy or bleeding diathesis

- Not pregnant or nursing

- Negative pregnancy test

- No serious medical illness, including any of the following:

- Uncontrolled congestive heart failure

- Uncontrolled angina

- Myocardial infarction

- Cerebrovascular event within 6 months prior to study entry

- No medical contraindication or potential problem that would preclude study compliance

PRIOR CONCURRENT THERAPY:

- At least 7 days since prior aspirin and aspirin-like medications

- At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds

- No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or
clopidogrel bisulfate)

- No concurrent participation in other experimental studies