A clinical trial is looking for sufferers of mesothelioma to examine the effects of a combination chemotherapy treatment in post-surgery pleural mesothelioma patients. The trials will be conducted by the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Massachusetts. The drugs being studied will be the chemotherapy drugs Cisplatin and Gemcitabine. Cisplatin is typically used in conjunction with other drugs, such as Alimta or Doxorubicin, as a cancer treatment. Coupling Cisplatin with Gemcitabine, the doctors are looking for any effects on mesothelioma tumors in patients who have already undergone surgery to remove part of the cancerous pleural lining of the lungs. Additionally, the study will be examining the effects of adding agents to the combination therapy to offset the toxic side effects of the chemotherapy. These will be amifostine and sodium thiosulfate. Amifostine is a typical addition to treatment with Cisplatin; it is used to protect the kidneys from damage.
Other cells of the body will receive protection from the chemotherapy with the use of sodium thiosulfate. Physicians seek to determine the maximum tolerated dose (MTD) of this combination therapy. The study also is looking at how much of this combination would be a toxic dose as well as the physical effects the drugs have on the body and the patient’s cancer. A total of two years is allotted for the study., which is defined as a Phase I clinical trial. Should this combination therapy be proven safe and effective during Phase I trials, further studies will be conducted on it. Most drugs take years of clinical trials to ensure their safety before they are released for use by the public. Since mesothelioma is such a rapidly fatal disease, patients who have undergone surgery are being encouraged to enroll. The trials will run from November 2008 through January 2010 beginning with recruiting in the last part of 2008. Interested patients should contact Dr. David Sugarbaker at the International Mesothelioma Program at 617-732-5004 or firstname.lastname@example.org. The trial identification number is NCT00571298.