The University of New Mexico Cancer Center recently enrolled its first patient in a phase 3 international clinical trial to test a personalized vaccine against metastatic kidney cancer. Kidney cancer has proven particularly difficult to treat with chemotherapy, and numerous attempts to create a kidney cancer vaccine have not improved survival rates. The phase 3 trial at the UNM Cancer Center tests a promising new approach: it uses a person's own kidney cancer cells to make a vaccine tailored to kill those cells.
"We've known for decades that there was an intimate relationship between the immune system and kidney cancer," says Richard Lauer, MD, FACP. Lauer serves as Chief Medical Officer and as principal investigator for the clinical trial at UNM Cancer Center. He says, "We know there have been spontaneous remissions in kidney cancer in which the immune system got activated and killed the cancer cells." But as previous vaccine attempts have shown, simply activating the immune system does not completely rid the body of kidney cancer.
"Our understanding of the immune system has become much more sophisticated," says Lauer. The new clinical trial's vaccine-making approach starts with the patient's own kidney cancer cells. Through a complex series of steps, the RNA in those cells is extracted and used to activate a type of immune cell called a dendritic cell. Dendritic cells activate another type of immune cell, called a T-cell, which destroy the invaders they are trained to recognize. T-cells kill not only tumor cells but also cells from the tumor that have spread to other parts of the body.
Other kidney cancer vaccines have activated T-cells and dendritic cells, but none as precisely as this approach. "This is a second generation dendritic cell vaccine," says Lauer. "We're personalizing it and activating it against the patient's own tumor. And the purpose of the clinical trial is to answer the question: how good is it? Does our current understanding of the technology help patients to get better?"
The UNM Cancer Center is one of 132 clinical trial sites worldwide, including sites in seven other countries. The trial will enroll about 900 people and will compare the standard kidney cancer treatment with the standard treatment plus the personalized vaccine. "This is a cutting-edge, state-of-the-art treatment," says Lauer. "We [the UNM Cancer Center] are excited to be a partner in this trial."
The clinical trial, entitled Phase 3 Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (RCC) (ADAPT), is currently recruiting patients.
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