Malignant Mesothelioma Clinical Trial
Official title:
Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)
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.
OBJECTIVES:
Primary
- To determine the 4-month progression-free survival in patients with unresectable
malignant pleural mesothelioma treated with everolimus.
Secondary
- To determine the response rate (confirmed and unconfirmed, complete and partial
responses) and disease control rate (response or stable disease) in patients with
measurable disease by RECIST and modified RECIST criteria.
- To determine overall survival of these patients.
- To evaluate the frequency and severity of toxicities associated with this treatment
regimen.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 3 years.
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