Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
Condition: Kidney Cancer; Lung Cancer; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lung Neoplasms; Neoplasm Metastasis; Kidney Neoplasms
Intervention: sargramostim; flow cytometry; immunoenzyme technique; biopsy; cryosurgery
Intervention description: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42; Days 1 & 32; Days 1 & 32; CT guided biopsy on days 1 & 32; Days 1 and 32
Intervention MeSH terms: Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: 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

Summary:

      RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving an injection of GM-CSF
      before cryotherapy and inhaling GM-CSF after cryotherapy may interfere with the growth of
      tumor cells and shrink the tumor. Giving cryotherapy together with GM-CSF may kill more tumor
      cells.

      PURPOSE: This phase II trial is studying how well giving cryotherapy together with GM-CSF
      works in treating patients with lung metastases or primary lung cancer.
    

Eligibility 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