Scientists and cancer researchers conducting a new stage in the clinical trials for the drug Vorinostat are looking for patients willing to test out this experimental treatment. With the successful completion of Phase II trials, Merck & Co., the company that manufactures the drug under the brand name Zolinza has announced that their research into this potential treatment is ready to undergo Phase III trials.
According to Merck officials, the Vorinostat trial will ascertain the safety, tolerance, and efficacy of the drug for patients suffering from advanced malignant pleural mesothelioma, a form of cancer that strikes the fluid sacs lining the lungs. When a patient receives a diagnosis, they typically live for another eighteen months to two years. The incidence of mesothelioma is frequently linked to long-term exposure to asbestos, a common material used for insulation and fireproofing in construction projects during the mid-twentieth century.
The drug (chemical name: suberoylanilide hydroxamic acid) is administered in the form of an oral tablet, as opposed to many chemotherapy drugs that are administered intravenously. At the start of the Phase III trial, patients selected to participate will either receive Vorinostat treatments or placebos, depending on a random drawing. During the trial, doctors and nurses will monitor the patient’s progress to determine the drug’s effectiveness in those who have received the treatment, as well as any potential “placebo effects” from those who only believe that they did.
Instead of testing the treatment on only a few dozen patients in the Phase II trials, the Phase III trial (titled “Suberoylanilide Hydroxamic Acid Vorinostat, MK0683 Versus Placebo in Advanced Malignant Pleural Mesothelioma“) will involve hundreds of potential participants from around the country. Recruiting efforts for the Phase III trials are underway in most major American cities, as well as in several other countries where Merck has established offices and research facilities.
Vorinostat is already available for the treatment of certain types of lymph node cancer, most notably, cutaneous T cell lymphoma (CTCL), a form of non-Hodgkin’s lymphoma that attacks the patient’s T-cells. This form of lymphoma, as well as the related disorder “Sézary’s disease”, cause painful eruptions on the skin as the disease tries to force the affected T-cells out of the body through the skin. The drug is also known to be effective as a supplemental treatment for non-small-cell lung cancer and may have potential as a treatment for T-cells affected by HIV.
In order to be eligible to participate in the Phase III study, patients must be at least eighteen years of age with a confirmed diagnosis of malignant mesothelioma. The patient must also have undergone unsuccessful treatments with the current drug remedies available, including cisplatin, carboplain and pemetrexed (brand name: Alimta). The patient must be able to take care of himself or herself, have sufficient functioning available in their liver, kidneys and bone marrow, in addition to the ability to swallow tablets.
A patient will not be eligible to participate in the study if they do not meet any of the above qualifications. A patient may also be excluded if they either have an infection or have undergone treatment with antibiotics two weeks prior to the start of the study, or if they have been treated with a similar drug under clinical trial conditions. Female patients may not participate if the are pregnant or nursing.
Sources: Merck, National Cancer Institute