Percutaneous Cryotherapy and Aerosolized GM-CSF for Pulmonary Metastases and Primary Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of 1 of the following:

- Primary non-small cell lung cancer (NSCLC)

- Any stage nonoperative NSCLC or patient refuses surgery

- Any cancer with pulmonary metastatic disease (including renal cell cancer)

- Stage IV disease (any T, any N, M1)

- Must have 1-10 pulmonary or mediastinal masses meeting the following criteria:

- At least 1 mass is appropriate for 2 sessions of core biopsy and cryotherapy
with relatively easy access/low risk in nonoperative patients (or those refusing
surgery)

- The two dominant masses are defined as either the largest and/or those that may
cause imminent morbidity from continued local progression, thereby potentially
benefiting from thoracic cryotherapy alone

- Optimal tumor size > 1.0 cm

- Dominant masses up to 6 cm in diameter may be considered if thorough
cryotherapy coverage can be anticipated with minimal additional treatment
morbidity

- Measurable disease, defined as tridimensional measurements of up to 6 different
pulmonary or mediastinal masses ≥ 0.5 cm by CT scan

- No active pleural effusion that could be related to respiratory infection or requires
further work-up

- No untreated and/or unstable brain metastases

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Life expectancy ≥ 12 weeks

- Granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 50,000/mm³

- INR < 1.5 (i.e., normal PT/PTT)

- Hemoglobin ≥ 8.0 g/dL

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- AST ≤ 3 times ULN

- Satisfactory pulmonary function test as determined by supervising oncologist,
thoracic surgeon, or pulmonologist

- Not pregnant or lactating

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the
cervix

- Inactive history of cancer allowed if the patient has been disease-free for > 2
years

- No serious medical or psychiatric illnesses that would preclude informed consent or
limit survival to < 12 wks

- No uncontrollable cough or inability to lie flat

- No New York Heart Association class III or IV heart disease

- No known immunodeficiency state

- No uncontrolled infection

- No uncontrolled coagulopathy or bleeding diathesis

- No advance directive that would prevent the investigator from treating the
participant in the event of a complication occurring during or after the procedure

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

PRIOR CONCURRENT THERAPY:

- More than 4 weeks since prior biologic therapy

- More than 4 weeks since prior immunotherapy

- More than 4 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- More than 4 weeks since prior radiotherapy

- More than 2 weeks since prior corticosteroids

- More than 1 week since prior parenteral antibiotics

- At least 1 week since prior aspirin or aspirin-like medications

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

- No concurrent GM-CSF other than study drug

- No concurrent G-CSF

- No concurrent radiotherapy

- No concurrent glucocorticosteroids

- No concurrent parenteral antibiotics

- No concurrent immunosuppressive agents

- No concurrent drugs that cause bleeding tendencies

- No other concurrent biologic therapy, immunotherapy, radiotherapy, or chemotherapy