Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma
Condition: Advanced Malignant Mesothelioma; Recurrent Malignant Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant; Lung Neoplasms
Intervention: sunitinib malate
Intervention description: Given orally
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well sunitinib works in treating patients with advanced
      malignant mesothelioma of the pleura. Sunitinib may stop the growth of tumor cells by
      blocking some of the enzymes needed for their growth.
    

Eligibility criteria:

        Criteria:

          -  Histologically or cytologically confirmed malignant pleural mesothelioma; Advanced or
             metastatic disease incurable by standard therapies

          -  Measurable disease, defined as at least 1 unidimensionally measurable lesion >= 20 mm
             by conventional techniques or >= 10 mm by spiral CT scan; No sole site of disease in a
             previously irradiated area unless there has been subsequent evidence of progression;
             Low-dose, palliative radiotherapy allowed

          -  Meets 1 of the following criteria for prior cytotoxic chemotherapy treatment:
             Previously treated with 1 platinum-based chemotherapy regimen; Previously untreated
             (i.e., no prior cytotoxic chemotherapy)

          -  No known brain metastases

          -  ECOG performance status 0-1

          -  Life expectancy >= 12 weeks

          -  Platelet count >= 100,000/mm^3

          -  Absolute granulocyte count >= 1,500/mm^3

          -  Bilirubin normal

          -  AST and ALT =< 2.5 times upper limit of normal

          -  Calcium =< 3 mmol/L

          -  Creatinine normal OR creatinine clearance >= 60 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Patients must reside within a 1.5 hour drive from participating center

          -  Able to take oral medication

          -  No other malignancy within the past 5 years except adequately treated nonmelanoma skin
             cancer, curatively treated in-situ carcinoma of the cervix, or any other curatively
             treated solid tumor

          -  No known history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to sunitinib malate

          -  No QTc prolongation (i.e., QTc interval >= 500 msec) or other significant ECG
             abnormalities

          -  No New York Heart Association (NYHA) class III or IV heart failure

          -  Patients with the following histories allowed provided they are asymptomatic with
             respect to cardiac function and LVEF is normal by MUGA at baseline: Anthracycline
             exposure, Central thoracic radiation that included the heart, NYHA class II cardiac
             function

          -  No uncontrolled hypertension (i.e., systolic blood pressure >= 140 mm Hg or diastolic
             blood pressure >= 90 mm Hg)

          -  No cardiac disease within the past 12 months, including any of the following:
             myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic
             congestive heart failure

          -  No pulmonary embolism within the past 12 months

          -  No cerebrovascular accident or transient ischemic attack within the past 12 months

          -  No bowel obstruction or any condition that would impair the ability to swallow and
             retain sunitinib malate, including any of the following:

        gastrointestinal tract disease resulting in an inability to take oral medication,
        requirement for IV alimentation, active peptic ulcer disease

          -  No serious illness or medical condition that would preclude study treatment including,
             but not limited to, any of the following: history of significant neurologic or
             psychiatric disorder that would impair the ability to obtain consent or limit
             compliance with study requirements, Active uncontrolled infection, Any other medical
             condition that might be aggravated by treatment, OR;

          -  Serious or nonhealing wound, ulcer, or bone fracture, Abdominal fistula,
             gastrointestinal perforation, or intra-abdominal abscess within the past 28 days

          -  No pre-existing hypothyroidism unless euthyroid on medication

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
             and recovered

          -  At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the
             following: Azole antifungals (e.g., ketoconazole, itraconazole, miconazole),
             Verapamil, Clarithromycin, HIV protease inhibitors (e.g., indinavir, saquinavir,
             ritonavir, atazanavir, or nelfinavir) Erythromycin, Delavirdine, Diltiazem

          -  At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the
             following: Rifampin, Phenytoin, Rifabutin, Hypericum perforatum (St. John's wort),
             Carbamazepine, Efavirenz Phenobarbital, Tipranavir

          -  At least 4 weeks since prior major surgery and recovered

          -  At least 4 weeks since prior radiotherapy and recovered

          -  At least 12 months since prior coronary/peripheral artery bypass graft or stenting

          -  No prior surgical procedures affecting absorption

          -  No prior radiotherapy that involved >= 30% of functioning bone marrow

          -  No prior treatment with any other antiangiogenic agents or multitargeted tyrosine
             kinase inhibitors, including any of the following:

        bevacizumab, sorafenib tosylate, pazopanib, thalidomide, AZD2171, vandetanib, AMG706,
        vatalanib, VEGF Trap

          -  No prior angiogenesis inhibitors except epidermal growth factor receptor inhibitors or
             other noncytotoxic therapy

          -  No other concurrent anticancer therapy or treatment with other investigational
             anticancer agents

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g.,
             warfarin); Doses =< 2 mg/day for prophylaxis of thrombosis or low molecular weight
             heparin for patients with an INR < 1.5 are allowed

          -  No concurrent agents with proarrhythmic potential, including any of the following:
             terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil,
             haloperidol, risperidone, indapamide, flecainide