Researchers initiate gene therapy trial in patients with advanced skin cancer

Researchers at the Ireland Cancer Center of University Hospitals Case Medical Center are the first in the region to have joined a nationwide clinical trial to evaluate the effectiveness of a gene therapy in patients with advanced melanoma which is aimed to help a patient ' s own immune system fight their cancer.

The gene therapy is termed Allovectin-7 ® , and is injected directly into the cancer while it is still in the body in order to make it appear foreign to the immune system. Previous studies using the gene therapy have shown that injection of a single site of cancer can train the immune system to fight other areas of the disease in the body which have not been injected with the gene.

“ Cancer cells often hide from the body ' s natural disease-fighting mechanisms because they arise from normal tissue and don ' t appear as foreign to the immune system, ” said Julian Kim, MD, Chief of Surgical Oncology and lead investigator of the study at University Hospitals Case Medical Center. “ The challenge in treating advanced melanoma is to find a way to train the patient ' s immune system to recognize cancerous cells as foreign which will help to eliminate them. The concept of injecting a gene into a cancer to make it appear as a foreign tissue essentially creates a personalized vaccine for each individual patient ' s cancer. The hope is that the newly formed cancer vaccine will trigger several of the body ' s natural immune response mechanisms to recognize and attack the cancer, both within the injected cancer and throughout the body. ”

The current Allovectin-7 ® study is focused upon patients who have advanced stages of the skin cancer termed melanoma. Melanoma is among the fastest-growing cancer diagnoses, with the number of new cases rising at a 3 to 5 percent annual rate during the last 30 years. Although early detection of melanoma results in many patients being cured by surgical removal of the melanoma, in a percentage of patients the disease will spread to other areas of skin or organs. The American Cancer Society estimates that in 2007 about 60,000 new cases of melanoma will be diagnosed in the United States and more than 8,000 patients will die from melanoma, suggesting that new treatments such as gene therapies and vaccines are needed.

University Hospitals Case Medical Center is the only regional center participating in the gene therapy trial and has joined 40 other melanoma centers nationwide to complete the study. Co-investigators at UHCMC include Henry Koon, MD, and CJ Nock, MD. The current study is a Phase III clinical trial, where patients are randomly assigned to be treated with either the Allovectin-7 ® gene therapy or traditional chemotherapy. Allovectin-7 ® has been previously administered to over 700 cancer patients in several multi-center clinical trials prior to the start of this study. To find out more information about this clinical trial or others at the Ireland Cancer Center, patients are encouraged to first visit www.melanomatrial.com. Patients can also call 1-800-641-2422 or visit the website www.irelandcancercenter.org .

“ The Ireland Cancer Center aims to bring the newest therapies to our patients and this new study is a prime example of bringing the latest research into our clinical practice, ” says Stanton Gerson, MD, Director of the Ireland Cancer Center. “ We are pleased to be able to offer this innovative gene therapy trial to patients in the Northeast Ohio region. ”

About University Hospitals

With 150 locations throughout Northeast Ohio, University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our Health System is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated Rainbow Babies & Children's Hospital, ranked best in the Midwest and first in the nation for the care of critically ill newborns; MacDonald Women's Hospital, Ohio's only hospital for women; and Ireland Cancer Center, which holds the nation's highest designation by the National Cancer Institute of Comprehensive Cancer Center.