S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
Condition: Malignant Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant; Lung Neoplasms
Intervention: everolimus
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent malignant mesothelioma; stage II malignant mesothelioma; stage III malignant mesothelioma; stage IV malignant mesothelioma

Summary:

      RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This phase II trial is studying how well everolimus works in treating patients with
      pleural malignant mesothelioma that cannot be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  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

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Serum bilirubin normal

          -  AST or ALT ≤ 1.5 times upper limit of normal (ULN)

          -  Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No evidence of bleeding diathesis or coagulopathy

               -  Previous pulmonary embolism allowed provided the patient is on therapeutic low
                  molecular weight heparin injections or warfarin AND no evidence of bleeding

                    -  Patients on therapeutic warfarin must have an INR of < 5 within 28 days
                       prior to registration

          -  No pathologic condition other than mesothelioma that carries a high risk of bleeding

          -  No known HIV positivity

          -  No gastrointestinal tract disease resulting in an inability to take oral or enteral
             medication via a feeding tube or a requirement for IV alimentation, or active peptic
             ulcer disease

          -  No other prior malignancy allowed except for any of 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

               -  Any other cancer from which patient has been disease-free for 5 years

        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