Clinical trial: CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer (NCT00079235)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Contradiction