Jul 23, 2012 - Doctors Investigating Everolimus as New Drug Therapy for Mesothelioma
Everolimus, marketed as Afinitor, is a multipurpose drug at the center a new round of mesothelioma clinical trials. The trials, sponsored by the Memorial Sloan-Kettering Cancer Center, are a first of their kind and were designed to use loss Merlin/NF2 (a specific biomarker) as a predictor of how well malignant mesothelioma sufferers would respond to this unorthodox treatment.
Everolimus is currently approved for the treatment of renal cell carcinoma as well as certain types of brain tumors, and has also been successfully used in conjunction with other drugs as an anti-rejection treatment for organ replacement patients. A kinase inhibitor, Everolimus interferes with the abnormal growth cycle of cancer cells and has been found to successfully halt tumor growth in other forms of cancer.
Researchers under Lee Krug, M.D., hoped to see similar performance when the drug was used to treat patients suffering from malignant mesothelioma. This particular Phase II clinical trial is similar to many in a new wave of mesothelioma research that closely examines the effectiveness of various existing cancer drugs against mesothelioma. Researchers, frustrated by the resistance mesothelioma shows to “traditional” chemotherapy treatments, have been experimenting with off-label use of various other cancer drugs (including in combination or “cocktail” form) to find a possible novel therapy that is as effective or – hopefully – more effective than current mesothelioma treatments.
The study is a collaborative effort between the Sloan-Kettering Cancer Center, the Dana-Farber Cancer Institute, and Novartis Pharmaceuticals, the manufacturer of Everolimus.
What makes this clinical trial slightly different, and therefore exciting, is that it has a built-in factor that could potentially increase the effectiveness of this specific drug therapy. Researchers added a mechanism to pre-determine which patients should respond most positively to the treatment. By measuring levels of Merlin/NF2 in samples from patients before treatments, scientists can then compare other variables and potentially discover what makes this treatment more or less effective in various patients.
If the results are as promising as Dr. Krug hopes, this could mean a tremendous leap forward in prognostics and the ability of mesothelioma doctors to successfully “weed out” unsatisfactory treatments before they waste valuable time with a “trial and error” approach in newly diagnosed mesothelioma victims.
In addition, researchers involved in this particular study were also actively trying to understand the relation between mesothelioma tumor growth and soluble mesothelin-related peptide (SMRP) and osteopontin. These biomarkers are typically overexpressed in mesothelioma victims – meaning that levels of these compounds are higher in mesothelioma patients than in the average population – but it’s not yet clear if that’s because the cancerous cells manufacture them at higher levels or if cells that manufacture abnormal levels of these chemical more easily become cancerous.
Because this study involved an untested mesothelioma drug, researchers were very careful to record measured physical effects of the drug both on the cancerous tumors and the patients themselves in hopes to gauge the safety of Everolimus as a mesothelioma treatment.
As with many clinical trials, in order to be eligible, patients must have endured unsuccessful chemotherapy treatments at least once.
The Phase II clinical trial began in 2009 and is scheduled to conclude in December of 2012.
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