Loyola University Medical Center 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.
The patient undergoes high-dose chemotherapy to kill most of his or her 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 their 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. 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.