Clinical trial offers patient ‘best shot’ at fighting kidney cancer

The human immune system has evolved many different kinds of cells that find and either kill or disable dangerous invaders. But even the strongest immune system cannot fight what it cannot see. Cancer cells that develop ways to make themselves invisible to the immune system, as Holmes' kidney cancer cells have done, can be particularly lethal. The phase 3 clinical trial that Holmes joined at the University of New Mexico Cancer Center strips the invisibility cloak from these spreading cancer cells. The trial uses Holmes' own cells to create a vaccine tailored for her cancer. "I'm getting a drug that is targeting, literally, my individual cancer at the cellular level," she says. "This is my best shot."

After diagnosing her cancer, Holmes' doctor referred her to the UNM Cancer Center. Her UNM medical team immediately repaired her arm bone, saving her arm and reducing her pain. But just before starting her on the standard course of treatment, Richard Lauer, MD, FACP, offered her the chance to take part in the phase 3 clinical trial. Facing an aggressive cancer in a vital organ, Holmes was happy to join. "If this gets the word out and helps one more person, that's a good legacy. I'd be happy with that," she had said.

Then her medical team explained that the clinical trial could help her, too. "When they said that, I told them, 'then it's a no-brainer!' " Holmes laughs. She joined the clinical trial then and there.

The phase 3 clinical trial compares the standard treatment for metastatic kidney cancer to the standard treatment plus the personalized vaccine. So, everyone in the phase 3 trial will receive surgery to remove the tumor, and radiation therapy and chemotherapy to remove any remaining tumor cells. But about two thirds of the people in the trial will receive the personalized vaccine as well; Holmes is one of those people. "I'm not giving up anything," she says. "I'm just getting something in addition."

Creating a personal vaccine

For decades, oncologists have known there was a link between kidney cancer and the immune system. "There have been innumerable attempts to make vaccines [to fight kidney cancer] over the years, to try to take advantage of the immune system," says Lauer. "And they have been uniformly disappointing."

Cancer vaccines have tried to mobilize several different types of cells of the immune system. Some vaccines activate T-cells, which kill or disable invaders. Other vaccines activate dendritic cells, which teach T-cells which invaders to go after and then activate those T-cells. Still other vaccines activate both types of immune cells.

This clinical trial uses a more personal approach. "We're activating the patient's dendritic cells against the patient's own tumor," says Lauer. "That's never been done. This is a new, innovative technology."

After her medical team rescued her arm, Holmes underwent endoscopic surgery to remove her cancerous kidney. The surgical team turned the kidney tumor over to the clinical trials team stationed in the adjoining surgical room. Holmes spent four days in the hospital and then two more weeks at home recovering from the four small incisions. Once recovered, Holmes then underwent a procedure called "leukapheresis," in which the clinical trials team removed some of her blood, removed her dendritic cells from the sample, and injected the rest of the blood back into her body.

The clinical trials team extracted RNA from Holmes' tumor cells and inserted it into her dendritic cells. Then they activated her dendritic cells. Holmes received an injection of these cells -- her personalized kidney cancer vaccine -- in her armpit, near her lymph nodes. In her lymph nodes, the activated dendritic cells will teach her T-cells to recognize and kill her cancer cells wherever they find them. Holmes will receive eight more injections of her personalized vaccine in her armpit over the next few months. "It sounds terrible," she says of the injections, "but it was nothing. I've had mosquito bites worse than that."

Holmes' medical team monitors her closely as she goes through her treatment. Holmes points out, "I am going through this. I am not stopping." So far, she has had no side effects.