Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and GM-CSF in Treating Patients With Recurrent, Refractory, or Metastatic Non-Small Cell Lung Cancer

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IV non-small cell lung cancer Read More

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

  • Recurrent, refractory, or metastatic disease after ≥ 1 prior first-line regimen (chemotherapy or radiotherapy)
• Documented EGFR-positive disease (any expression level) by immunohistochemistry (IHC) (may be based on archival sample)
• Measurable or evaluable disease by radiograph, CT scan, MRI, and/or physical exam
• Appropriate slides of the primary lesion must be available for review of IHC staining assessment by a central pathology team

• No clinical evidence of active brain metastases

  • Patients with brain metastases are eligible provide they have received definitive radiotherapy or chemotherapy and/or have undergone surgical resection for brain metastases
• No prior hematological malignancy

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) 60-100% OR ECOG PS 0-2
• Life expectancy ≥ 3 months
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Granulocytes ≥ 1,000/mm^3
• Platelet count ≥ 50,000/mm^3
• Hemoglobin ≥ 8 g/dL
• BUN ≤ 2.0 times normal
• Serum creatinine ≤ 2.0 mg/dL
• Bilirubin ≤ 1.5 times normal
• SGOT ≤ 1.5 times normal (with or without liver metastases)
• Hepatitis B surface antigen and HIV negative

• LVEF ≥ 45 % at rest (by MUGA)

  • No evidence of depressed left ventricular function
• FEV_1, DLCO, and FVC ≥ 50% of the predicted value

• No other malignancy, except for the following:

  • History of curatively treated in situ squamous cell carcinoma or basal cell carcinoma of the skin
  • History of other curatively treated malignancy (except those with a hematologic origin) for which the patient has remained in complete remission > 5 years after completing therapy (as documented by history, physical exams, tumor markers, and radiology scanning)
• No serious medical or psychiatric illness that would preclude giving informed consent or receiving intensive treatment
• No recent myocardial infarction (within the past year)
• No current angina/coronary symptoms requiring medications
• No clinical evidence of congestive heart failure requiring medical management (irrespective of MUGA results)

• No systolic blood pressure (BP) ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg

  • Patients with elevated BP must have it controlled by anti-hypertensive medications for at least 7 days prior to the first infusion

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy or radiotherapy
• At least 4 weeks since prior cetuximab or small molecule EGFR-inhibitors including, but not limited to, gefitinib or erlotinib hydrochloride
• No concurrent radiotherapy
• No concurrent steroids except for treatment of adrenal failure, septic shock, or pulmonary toxicity or hormones for non-disease-related conditions (e.g., insulin for diabetes)