Clinical Trial for Metastatic Melanoma to Begin Early Next Year

News Archive September 29, 2011

Clinical Trial for Metastatic Melanoma to Begin Early Next Year

MAYWOOD, Ill.  -- A new cancer research program at Loyola University Chicago Stritch School of Medicine will develop therapies designed to turn patients' own immune systems into potent weapons against cancer.

The first project is an immune system therapy for metastatic melanoma. A clinical trial, expected to begin early next year, will be the only one of its kind in the Midwest.

The Immunotherapeutics Program at the Cardinal Bernardin Cancer Center is directed by Michael I. Nishimura, PhD,  principal investigator of a new five-year, $16.3 million grant from the National Cancer Institute.

Nishimura's lab will include eight to 10 scientists. "Our goal will be to create novel therapies for the treatment of advanced malignancies," he said.

Loyola recently recruited Nishimura from the Medical University of South Carolina, where he was a professor in the Department of Surgery and scientific director of the Center for Cellular Therapy. Before that, he was an associate professor at the University of Chicago and a staff scientist at the National Cancer Institute. He earned his PhD from the University of Maryland, which named him the 2010 Outstanding Alumnus of the Year in the Natural and Mathematical Sciences.

"Immunotherapeutics holds great promise in treating cancers, and Dr. Nishimura is a nationally recognized leader in the field," said Dr. Paul C. Kuo, chairman of the Department of Surgery and director of the Oncology Institute at Loyola University Chicago Stritch School of Medicine.

Nishimura's lab will develop a new treatment involving T lymphocytes. T lymphocytes are a type of white blood cells ­-- also known simply as T cells. T cells play a critical role in the immune system. One type of T cell, known as a killer T cell, attaches to and kills cells it recognizes as abnormal.

In the experimental melanoma treatment, a batch of T cells will be removed from the patient and genetically modified in the lab. Two genes will be inserted into the cells so that they recognize tumor cells as abnormal. The cells will be prepared in the Robert R. McCormick Foundation Center for Cellular Therapy in the Cardinal Bernardin Cancer Center.

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

A Phase 1 clinical trial of as many as 15 patients will begin early next year. (Patient recruitment will not begin until the trial receives all regulatory approvals and is officially launched.)

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. Phase 2 would begin in about two years and include 32 to 36 patients.

The clinical trial will be conducted at the Cardinal Bernardin Cancer Center. "This new program will significantly enhance our existing immunotherapy programs for pancreatic and ovarian cancers, which are supported by the Richard A. Perritt Charitable Foundation," said Dr. Patrick Stiff, director of the Cardinal Bernardin Cancer Center.

Nishimura's co-investigators are Patrick Stiff, MD; Joseph Clark, MD; Constantine Godellas, MD; Kelli Hutchens, MD; and Caroline Le Poole, PhD.

Melanoma is the sixth-most-common cancer in Americans, and the most common fatal malignancy in young adults. Incidence 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.

In addition to being program leader of the Immunotherapics Program, Nishimura is a professor in the Department of Surgery and associate director of the Oncology Institute of Loyola University Chicago Stritch School of Medicine.

Loyola University Chicago Stritch School of Medicine is located in a state-of-the-art educational facility on the campus of Loyola University Medical Center, 2160 S. First Ave., Maywood. The school, which provides instruction to 520 medical students, has been in the vanguard of institutions that have created new, active learning curricula to help students meet the challenges of 21st century health care. An estimated 8,000 to 9,000 students compete each year for 130 openings in the Stritch medical school's first-year class. In addition to the more than 500 students, Loyola's medical educational programs provide instruction and training to an estimated 400 residents and 100 fellows.
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