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Title:
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A Phase II Trial of mTOR Inhibitor, Everolimus, (RAD001) in Malignant Pleural Mesothelioma (MPM) - IRB# 09-46B
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Treatments:
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Everolimus
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Disease Site:
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Lung
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Disease SubSite:
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Drug Provided:
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Everolimus
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Comments:
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Eligibility:
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Histologically confirmed malignant pleural mesothelioma, unresectable disease, must have measurable or nonmeasurable disease by RECIST or modified RECIST criteria. Must have received prior systemically administered* platinum-based chemotherapy and meets the following criteria: No more than 2 prior systemic therapeutic regimens allowed (including biologics, targeted, and immunotherapies). At least 1 regimen must have been platinum-based, neoadjuvant and/or adjuvant systemic therapy is not counted as a prior regimen, assuming =>12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease.[Note: *Pleural space washing with cisplatin does not constitute systemic administration], No known CNS metastases, Prior/Concurrent Therapy: See Disease Characteristics. Recovered from all prior therapy. At least 28 days since prior systemic therapy (42 days for nitrosoureas or mitomycin C). At least 28 days since prior thoracic or other major surgery (e.g., pleurectomy or pleurodesis) and no anticipated need for major surgical procedures during study. At least 14 days since prior radiotherapy. No prior surgical procedure affecting absorption. No prior chronic, systemic corticosteroids or other immunosuppressive agent, except corticosteroids equivalent to prednisone =< 20 mg daily. Must have been on a stable dosage regimen for => 4 weeks. Topical and inhaled corticosteroids allowed. No prior mTOR inhibitor therapy (i.e., rapamycin, everolimus, or temsirolimus). No concurrent immunization with attenuated live vaccines. No concurrent antiretroviral therapy for HIV-positive patients. No other concurrent investigational therapy. No other concurrent anticancer agents.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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