About one year ago, Anne Holmes saw her doctor for a nagging pain in her upper arm. She learned that cancer cells from a massive tumor on her left kidney had invaded the long bone in her right arm and nearly ate through it, causing the pain. “I’m very lucky,” says Holmes. “It could have spread to my heart, my lungs, my brain. It could have gone to worse places.” Now Holmes plans to rid her body of all her cancer cells and, at the same time, help others with metastatic kidney cancer. She is the first New Mexican to join a clinical trial that will teach her immune system to fight her cancer cells everywhere.
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.”
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.
Her medical team will watch her condition carefully for the entire clinical trial, which includes some time after the injections end. “I’m delighted to be part of the study,” she says. “I have a wonderful team and I have the best chance right here.”
Richard Lauer, MD, FACP, is a Professor in the Division of Hematology/Oncology in the UNM Department of Internal Medicine at the UNM School of Medicine. He serves as Chief Medical Officer at the UNM Cancer Center and is the Maralyn S. Budke Endowed Professor in Cancer Care Delivery. Trained at New York Medical College and Indiana University, Dr. Lauer is an international expert in the treatment of genitourinary cancers and the delivery of high quality, integrated cancer care in academic settings, blending comprehensive cancer diagnosis and treatment with clinical research. He has served as principal investigator for several clinical trials, many for treatment of kidney cancers and some that he created and developed. As Chief Medical Officer of the UNM Cancer Center, Dr. Lauer is responsible for all clinical aspects of the UNM Cancer Center’s operations. Dr. Lauer has published several papers on kidney cancer and serves on the National Cancer Institute’s National Clinical Trials Network Renal Task Force.
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. Learn more about the clinical trial at https://clinicaltrials.gov/ct2/show/study/NCT01582672.
Argos Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases. The company has developed a pipeline of products based on its proprietary Arcelis technology platform. Learn more at http://www.argostherapeutics.com/
The UNM Cancer Center is the Official Cancer Center of New Mexico and the only National Cancer Institute-designated Cancer Center in the state. One of just 68 premier NCI-Designated Cancer Centers nationwide, the UNM Cancer Center is recognized for its scientific excellence; contributions to cancer research; delivery of high quality, state of the art cancer diagnosis and treatment to all New Mexicans; and its community outreach programs statewide. Annual federal and private funding of more than $72 million supports the UNM Cancer Center’s research programs. The UNM Cancer Center treats more than 60 percent of the adults and virtually all of the children in New Mexico affected by cancer, from every county in the state. It is home to New Mexico’s largest team of board-certified oncology physicians and research scientists, representing every cancer specialty and hailing from prestigious institutions such as M.D. Anderson Cancer Center, Johns Hopkins University, and the Mayo Clinic. Through its partnership with Memorial Medical Center in Las Cruces, the UNM Cancer Center brings world-class cancer care to the southern part of the state; its collaborative clinical programs in Santa Fe and Farmington serve northern New Mexico and it is developing new collaborative programs in Alamogordo and in Roswell/Carlsbad. The UNM Cancer Center also supports several community outreach programs to make cancer screening, diagnosis and treatment available to every New Mexican. Learn more at www.cancer.unm.edu.