Loyola University Medical Center in Chicago is currently enrolling melanoma patients in a Phase I clinical trial for an experimental immunotherapy vaccine. The treatment will consist of ex vivo collection of the patient’s T cells to be genetically modified through the insertion of two genes, allowing them to improve tumor cell recognition. Patients will have to undergo high-dose chemotherapy to kill the majority of their remaining T cells, allowing space for the modified T cells that are inserted back in the patient.
The main objective of this trial’s initial phase is to determine the optimum dose and safety of the treatment.
Four different doses will be tested, with the highest dose consisting of about 5 billion genetically modified T cells. If Phase I proves successful, researchers will proceed to Phase 2, eventually determining if the treatment is effective.
Michael I. Nishimura, PhD, director of the Immunotherapeutics Program at Loyola’s Cardinal Bernardin Cancer Center was the developer behind this experimental immunotherapy.
The cells will be prepared in the Robert R. McCormick Foundation Center for Cellular Therapy in the Bernardin Cancer Center and the trial will partly by funded by a $16.3 million grant from the National Cancer Institute. “Our goal is to create novel therapies for the treatment of advanced malignancies,” said Dr. Nishimura in a Loyola University press release.
“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,” Joseph Clark, MD, one of the principal investigators of the trial added in the press release.
So far, at least one patient with stage-4 melanoma currently participating in the trial has reported improvement.
According to the American Cancer Society, if melanoma is detected early, the odds of surgery being successful are significantly high. However, if the cancer is metastatic, the five-year survival rate is only 15 to 20%.
“This is a terrible, devastating disease. 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, and our clinical trial is designed for patients who have no other options.” Dr. Clark said in the press release.