Conditions: Malignant Mesothelioma
Keywords: recurrent malignant mesothelioma stage II malignant mesothelioma stage III malignant mesothelioma stage IV malignant mesothelioma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 61
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Daily oral Everolimus 10 mg/day

Interventions: intervention 1: everolimus
Intervention descriptions: intervention 1: None

Protocol document: