Tuesday, November 19, 2013

Loyola recruiting melanoma patients for clinical trial of innovative treatment vaccine

Vaccine trains immune system to attack cancer

Michael I. Nishimura, PhD, (left) is director of the Immunotherapeutics Program at Loyola's Cardinal Bernardin Cancer Center. Joseph Clark, MD, is one of the principal investigators of the trial.

Loyola University Medical Center in Maywood, Ill., is enrolling melanoma patients in the first clinical trial in the Midwest of an experimental vaccine that trains a patient's immune system to fight the deadly cancer.

A batch of the immune system's killer T cells are removed from the patient and genetically modified in a Loyola lab. Two genes are inserted into the T cells so that they will recognize tumor cells as abnormal.

Patients undergo high-dose chemotherapy to kill most of their remaining T cells. This will make room for the genetically modified T cells when they are put back in the patient. The modified T cells, it is hoped, will recognize the tumor cells as abnormal and then attack and kill them.

"This clinical trial is a unique attempt to manipulate a person's own immune system to attack the cancer in a more effective and specific manner," said Joseph Clark, MD, one of the principal investigators of the trial.

The purpose of the Phase 1 trial is to determine the optimum dose and whether the treatment is safe. Four doses will be tested, with the highest dose consisting of about 5 billion genetically modified T cells. If Phase 1 demonstrates the treatment is safe, investigators will proceed to Phase 2, which will determine whether the treatment is effective.

Melanoma is the sixth most common cancer in Americans, and the most common fatal malignancy in young adults. The number of reported cases is rising dramatically. About 1 in 50 people will be diagnosed with melanoma. In the 1960s, it was 1 in 600.

Surgery is highly successful if the cancer is caught early. But if the cancer has spread to other parts of the body, the five-year survival rate is only 15 to 20 percent, according to the American Cancer Society.

"This is a terrible, devastating disease," Clark said. "It starts on the skin and can spread to just about anywhere in the body." The clinical trial is open to patients with metastatic melanoma who are no longer responding to standard therapy. "We need better treatments," Clark said. "Our clinical trial is designed for patients who have no other options."

The experimental immune system therapy was developed by Michael I. Nishimura, PhD, director of the Immunotherapeutics Program at Loyola's Cardinal Bernardin Cancer Center. The cells will be prepared in the Robert R. McCormick Foundation Center for Cellular Therapy in the Bernardin Cancer Center. Nishimura is principal investigator of a five-year, $16.3 million grant from the National Cancer Institute. "Our goal is to create novel therapies for the treatment of advanced malignancies," he said.

Additional funding for the trial comes from a National Cancer Institute grant to Lentigen Corp., which makes the agent that delivers the genes to the T cells, and from the American Recovery and Reinvestment Act (the economic stimulus bill).

Clark is a professor in the Department of Medicine, Division of Hematology/Oncology of Loyola University Chicago Stritch School of Medicine. Nishimura is a professor in the Department of Surgery and associate director of the Oncology Institute of Loyola University Chicago Stritch School of Medicine.
Other investigators in the trial are Patrick Stiff, MD, director of the Cardinal Bernardin Cancer Center; Constantine Godellas, MD; Kelli Hutchens, MD; and Caroline LePoole, PhD.

For more information, please call (708) 327-3221.

About Loyola University Health System

Loyola University Health System (LUHS) is part of Trinity Health. Based in the western suburbs of Chicago, LUHS is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and more than 30 primary and specialty care facilities in Cook, Will and DuPage counties. Loyola University Medical Center’s campus is conveniently located in Maywood, 13 miles west of Chicago’s Loop and 8 miles east of Oak Brook, Ill. At the heart of the medical center campus is a 559-licensed-bed hospital that houses a Level 1 Trauma Center, a Burn Center and the Ronald McDonald® Children's Hospital of Loyola University Medical Center. Also on campus are the Cardinal Bernardin Cancer Center, Loyola Outpatient Center, Center for Heart & Vascular Medicine and Loyola Oral Health Center as well as Loyola University Chicago Stritch School of Medicine, Loyola University Chicago Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola's Gottlieb campus in Melrose Park includes the 255-licensed-bed community hospital, the Professional Office Building housing 150 private practice clinics, the Adult Day Care, the Gottlieb Center for Fitness, Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park.

Trinity Health is a national Catholic health system with an enduring legacy and a steadfast mission to be a transforming and healing presence within the communities we serve. Trinity is committed to being a people-centered health care system that enables better health, better care and lower costs. Trinity Health has 88 hospitals and hundreds of continuing care facilities, home care agencies and outpatient centers in 21 states and 119,000 employees.