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

About this trial
This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22.