The Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity trial, held in New York City, is recruiting patients with pleural mesothelioma, a type of asbestos cancer. The study’s primary aim is to determine the rate of response at 16 weeks for patients with pleural mesothelioma treated with everolimus as either a second or third line therapy.
The trial’s secondary goals include determination of response rate, time to progression and overall survival for patients with mesothelioma who are treated with everolimus, as well as to determine the toxicities of the pharmaceutical. The trial aims to explore whether or not Merlin/NF2 loss can be used to predict sensitivity to everolimus, and to determine the relationship between the responses to treatment and levels of soluble mesothelin-related peptide and osteopontin.
The study, which was last updated on ClinicalTrials.gov on December 11, 2009, has an estimated enrollment of 39 patients. The study began on December 2, 2009.
Malignant mesothelioma is a type of cancer in the lining of the chest or abdomen. Individuals with past exposure to asbestos particles are more likely to develop the disease. It is typically treated with mesothelioma surgery, radiation therapy, chemotherapy or a combination of the three.
Both men and women 18 years and older are eligible to participate in the study as long as they have a histologically confirmed diagnosis of malignant pleural mesothelioma that is not amenable to surgery. They must also have measurable disease according to the modified RECIST mesothelioma criteria and adequate tissue sample available for analysis.
Potential patients must have had no more than two prior systemic therapy regimens. At least one of these prior regimens must have included pemetrexed. A recruit’s Karnofsky performance should be greater than or equal to 70%. Adequate renal function and signed informed consent are required in order to participate.
Patients will be excluded from the study if they have been previously treated with an mTOR inhibitor, and those who have received, within 3 weeks of the study, any anticancer therapies will be unable to participate, in addition to patients who have had major surgeries or traumatic injuries within 4 weeks of the study.
Recruits must not have received prior mesothelioma treatment with investigational drugs within the 4 weeks preceding the trial. Patients will be excluded if they are receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agents, or if they received immunization with attenuated live vaccines within one week of the study.
Patients with severe or uncontrolled medical conditions, such as diabetes or heart failure may not participate. Individuals with liver disease or severely impaired lung function will be excluded. Female patients who are pregnant or breast feeding cannot participate, as well as patients with history of HIV seropositivity or impairment of gastrointestinal function. Patients with an active, bleeding diathesis cannot participate, nor can patients with a ‘currently active’ second malignancy or an active infection for which they received medications within two weeks of the study.
