CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer

Inclusion Criteria:

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

  • Stage IIIB (with pleural effusion) or IV disease

• Measurable disease

  • At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan

  • The following are not considered measurable disease:

    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Inflammatory breast disease
    • Lymphangitis cutis/pulmonis
    • Cystic lesions
    • Abdominal masses that are not confirmed and followed by imaging techniques
• Blood and tissue blocks available
• Must have accessible tumor (i.e., superficial lesions such as lymph node, subcutaneous nodules) to provide core needle biopsy tissue before and during study treatment
• No known brain metastases
• Performance status - ECOG 0-2
• At least 12 weeks
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL
• Bilirubin ≤ 2 times upper limit of normal (ULN)
• AST ≤ 3 times ULN (5 times ULN if hepatic metastases are present)
• Creatinine ≤ 1.5 times ULN
• Serum fasting cholesterol ≤ 350 mg/dL
• Serum fasting triglycerides ≤ 400 mg/dL
• HIV negative
• No uncontrolled infection
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or non-invasive carcinomas
• No concurrent severe underlying disease that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study treatment
• No prior biologic therapy
• No prior gene therapy
• No prior immunotherapy
• No concurrent immunotherapy
• No concurrent prophylactic growth factors to support neutrophil count
• No prior chemotherapy for NSCLC except low-dose cisplatin as a radiosensitizer
• No other concurrent chemotherapy
• No concurrent dexamethasone (10 mg IV)
• No prior radiotherapy to 30% or more of bone marrow
• Concurrent radiotherapy for underlying malignancy and non-target sites (e.g., painful pre-existing bony metastasis) allowed
• No other concurrent investigational therapy
• No concurrent immunosuppressive therapy