Clinical trial: Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma (NCT00509041)

Eligibility criteria:
DISEASE CHARACTERISTICS:

          -  Histologically confirmed malignant mesothelioma of any of the following subtypes:

               -  Epithelial

               -  Sarcomatoid

               -  Mixed

          -  Any site of origin of malignant mesothelioma allowed including, but not limited to,
             any of the following:

               -  Pleura

               -  Peritoneum

               -  Pericardium

               -  Tunica vaginalis

          -  Pathology blocks or slides from a core surgical biopsy must be available

          -  Not amenable to curative surgery

          -  Measurable disease, defined as lesions that can be accurately measured in at least one
             dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques
             (CT scan , MRI, or x-ray) or as ≥ 10 mm with spiral CT scan

               -  Patients with pleural rind only disease must have at least one level with one
                  rind measurement ≥ 1.5 cm

               -  Lesions that are considered nonmeasurable include the following:

                    -  Bone lesions

                    -  Leptomeningeal disease

                    -  Ascites

                    -  Pleural/pericardial effusion

                    -  Lymphangitis cutis/pulmonis

                    -  Abdominal masses that are not confirmed and followed by imaging techniques

                    -  Cystic lesions

          -  Prior treatment with one and only one systemic chemotherapy regimen, which must have
             included pemetrexed disodium required

               -  Treatment may have been with pemetrexed disodium alone or in combination with any
                  other agent

          -  No symptomatic pleural effusions, unless the patient undergoes a therapeutic
             thoracentesis

               -  Patients with pleural effusions who have had a pleurodesis are eligible

          -  No known brain metastases

          -  May be registered on CALGB-150707 companion study

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Granulocytes ≥ 1,500/μL

          -  Platelet count ≥ 100,000/μL

          -  Total bilirubin ≤ 2 x upper limit of normal (ULN)

          -  AST (SGOT) ≤ 2.5 x ULN

          -  Creatinine clearance ≥ 60 mL/min

          -  INR < 1.5

          -  PTT < 40 seconds

          -  QTc < 450 msec

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No significant cardiac disease, including any of the following:

               -  New York Heart Association (NYHA) class III-IV congestive heart failure (CHF)

               -  Unstable angina

               -  Myocardial infarction or ventricular tachyarrhythmia within 6 months of study
                  entry

               -  Ejection fraction less than institutional normal (in patients with a history of
                  CHF or currently with NYHA class I or II CHF)

               -  Prolonged QTc > 450 msec (Fridericia correction)

               -  Major conduction abnormality, unless a cardiac pacemaker is present

               -  Hypokalemia or hypomagnesemia that cannot be corrected

          -  No history of significant bleeding disorder unrelated to cancer, including any of the
             following:

               -  Congenital bleeding disorder (e.g., von Willebrand disease)

               -  Acquired bleeding disorder within the past year (e.g., acquired anti-factor VIII
                  antibodies)

               -  Ongoing or recent (≤ 3 months) significant GI bleeding or hemoptysis

          -  No requirement for supplemental oxygen (i.e., pulse oximetry < 89% at rest)

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior pemetrexed disodium-containing chemotherapy

          -  At least 4 weeks since prior major surgery

          -  At least 4 weeks since prior radiation therapy

               -  Measurable disease must be outside the radiation port

          -  Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed

               -  Intrapleural cytotoxic chemotherapy will not be considered systemic chemotherapy

          -  At least 7 days since prior and no concurrent antithrombotic or anti-platelet agents,
             including any of the following:

               -  Aspirin or aspirin-containing combinations

               -  Clopidogrel

               -  Dipyridamole

               -  Tirofiban

               -  Epoprostenol

               -  Eptifibatide

               -  Cilostazol

               -  Abciximab

               -  Ticlopidine

               -  Warfarin

                    -  Low-dose warfarin for prophylaxis to prevent catheter thrombosis allowed

               -  Heparin or low molecular weight heparin

                    -  Heparin for IV line flush allowed

          -  At least 7 days since prior and no concurrent use of the following drugs:

               -  Itraconazole

               -  Ketoconazole (at doses > 200 mg/day)

               -  Miconazole

               -  Voriconazole

               -  Telithromycin

               -  Primidone

               -  Rifabutin

               -  Rifampin

               -  St. John's wort

               -  Carbamazepine

               -  Oxcarbazepine

               -  Rifapentine

               -  Phenobarbital

               -  Phenytoin

               -  Quinidine

               -  Procainamide

               -  Disopyramide

               -  Amiodarone

               -  Sotalol

               -  Ibutilide

               -  Dofetilide

               -  Erythromycin

               -  Clarithromycin

               -  Chlorpromazine

               -  Haloperidol

               -  Mesoridazine

               -  Thioridazine

               -  Pimozide

               -  Bepridil

               -  Droperidol

               -  Halofantrine

               -  Levomethadyl

               -  Sparfloxacin

          -  No concurrent H2 blockers or proton pump inhibitors

          -  No bisphosphonate therapy during the first 8 weeks of study treatment

          -  No concurrent hormones or other chemotherapeutic agents except for steroids
             administered for dasatinib-related pleural effusion or hormones administered for
             non-disease-related conditions (e.g., insulin for diabetes)

          -  No concurrent palliative radiation 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? 1