Clinical trial: Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura (NCT00019825)

Eligibility criteria:
DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed unresectable primary small cell lung cancer
             (SCLC) or non-small cell lung cancer (NSCLC), unresectable esophageal cancer,
             malignant pleural mesothelioma, or pleural effusions secondary to extrathoracic
             malignancies

          -  Disease must be readily accessible to biopsy by endoscopy or percutaneous fine-needle
             aspiration

          -  Extrathoracic metastatic disease allowed if no evidence of active intracranial or
             leptomeningeal metastases

               -  Patients treated with prior resection or radiotherapy for intracranial metastatic
                  disease may be eligible provided there is no evidence of active disease on two
                  MRIs (taken one month apart) and patients require no anticonvulsant medications
                  or steroids to control residual symptoms

          -  No limited stage SCLC or operable NSCLC

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  ECOG 0-2

        Life expectancy:

          -  At least 6 months

        Hematopoietic:

          -  Platelet count greater than 100,000/mm^3

          -  Hemoglobin greater than 10 g/dL

          -  WBC greater than 3,500/mm^3

        Hepatic:

          -  PT normal

          -  Bilirubin less than 1.5 times upper limit of normal

        Renal:

          -  Creatinine no greater than 1.6 mg/dL OR

          -  Creatinine clearance greater than 60 mL/min

        Cardiovascular:

          -  Any of the following conditions require clearance by a cardiologist:

               -  Prior coronary artery disease

               -  Prior transmural myocardial infarction

               -  Congestive heart failure

               -  Fixed defects on thallium scan with ejection fraction greater than 40%

          -  No unstable angina

          -  No recent deep venous thrombosis requiring anticoagulation

        Pulmonary:

          -  FEV1 and DLCO greater than 30% of predicted

          -  pCO_2 less than 50 mm Hg

          -  pO_2 greater than 60 mm Hg on room air

          -  No recent pulmonary embolism requiring anticoagulation

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active infection

          -  HIV negative

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 30 days since prior biologic therapy for the malignant tumor

        Chemotherapy:

          -  No prior decitabine

          -  At least 30 days since other prior chemotherapy for the malignant tumor

        Endocrine therapy:

          -  See Disease Characteristics

        Radiotherapy:

          -  See Disease Characteristics

          -  At least 30 days since prior radiotherapy for the malignant tumor (14 days for
             localized radiotherapy to nontarget lesions) and recovered

        Surgery:

          -  See Disease Characteristics
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? 1