A Phase II Trial of mTOR Inhibitor, Everolimus, (RAD001) in Malignant Pleural Mesothelioma (MPM)

Histologically confirmed diagnosis of unresectable malignant pleural mesothelioma. Must have measurable or non-measurable disease documented by CT scan. Measurable disease must be assessed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. Must have had prior systemically administered platinum-based chemotherapy. Pleural space washing with cisplatin does not constitute systemic administration. No more than two prior systemic therapeutic regimens are allowed (including biologics, targeted and immunotherapies), and at least one regimen must have been platinum-based. Must have completed systemic therapy (including any chemotherapy, biologics, targeted and immunotherapies) 28 days (42 days for nitrosoureas or mitomycin C) prior to registration. May have received prior surgery (e.g., pleurectomy, pleurodesis) provided that at least 28 days have elapsed since surgery (thoracic or other major surgeries). Must be no anticipated need for major surgical procedures during protocol treatment. Must not have known CNS metastases. Institutions must offer patients participation in correlative studies. May have received prior radiation therapy provided that at least 14 days have elapsed since the last treatment. Must not have received chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone 20 mg. Patients receiving corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior to the first planned treatment with everolimus. Topical or inhaled corticosteroids are allowed. Must not have had prior mTOR inhibitor therapy (rapamycin, everolimus, temsirolimus [CCI-779], AP23573). Must not be planning to receive immunization with attenuated live vaccines. Zubrod 0 -1. Must have adequate hematologic function as documented by an ANC >/= 1,500/mcl and a platelet count >/= 100,000/mcl obtained within 28 days prior to registration. Must have adequate hepatic function as evidenced by serum bilirubin <\= institutional upper limit of normal (IULN). SGOT (AST) or SGPT (ALT) must be </= 1.5 x IULN. These tests must be obtained within 28 days prior to registration. Must have a serum creatinine </=1.5 x IULN or a calculated or measured creatinine clearance >/= 50 mL/min. These tests (including creatinine [mg/dl] if using calculated creatinine clearance) must be obtained within 28 days prior to registration. Must have no evidence of bleeding diathesis or coagulopathy. Must have no pathologic condition other than mesothelioma that carries a high risk of bleeding. Must not be known to be HIV-positive and on antiretroviral therapy. Must not have gastrointestinal tract disease resulting in an inability to take oral or enteral medication via a feeding tube or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease. Must not be pregnant or nursing. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.