Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer

This is an interventional treatment trial for Kidney Cancer focused on measuring lung metastases, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, recurrent renal cell cancer, stage IV renal cell cancer, unspecified adult solid tumor, protocol specific Read More

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