The pharmaceutical giant Merck has announced that it will continue its phase III clinical trial investigating the efficacy of vorinostat on patients with advanced malignant pleural mesothelioma (MPM).
Vorinostat, which is marketed as Zolinza, is already FDA-approved for the treatment of cutaneous T-cell lymphoma.
It is an oral histone deacetylase inhibitor, and will be studied as a second-line chemotherapy treatment for MPM patients who have already received treatment involving the commonly used drug pemetrexed, or Alimta, in combination with cisplatin or carboplatin. Its efficacy for patients who are ineligible for pemetrexed-based protocol will also be studied.
The trial, known as VANTAGE-14, has enrolled more than half of the necessary patients, and is currently recruiting mesothelioma patients who are being treated by cancer centers in the United States, the United Kingdom, Belgium, Germany, the Netherlands, Spain, Sweden and New Zealand. Mesothelioma, a cancer which is caused almost exclusively by previous exposure to asbestos, may take up to 50 years to surface. Its symptoms include shortness of breath, wheezing, a bloody or persistent cough, chest in the neck, back, side or chest, and fatigue. Some patients also experience swelling of the neck or face, and difficulty swallowing.
Mesothelioma has a median survival time of only six to 18 months, and is difficult to treat using conventional therapies. VANTAGE-14 will study the effects of vorinostat on survival rate as well as investigating its safety and toxicity. The trial is a randomized, double-blind trial in which the patients who receive Vorinostat will compared to those who are given placebo. Mesothelioma, a cancer affecting the membrane that lines the lungs, affects 3,000 new patients each year.
Because of the length of time it takes for the cancer to develop and become symptomatic—and therefore to be diagnosed—it is usually only discovered at the latest stages, when surgery is not an option and when the patient is sometimes too weak to undergo the debilitating side effects commonly associated with the current chemotherapy drugs approved for use on malignant pleural mesothelioma.