Dr. John Lee receives FDA approval for national clinical trial.
(Sioux Falls, SD) – A new Sanford clinical trial will study the safety and effectiveness of a drug treatment on patients receiving radiation and chemotherapy for head and neck cancer.
About three to five percent of all cancers reported in the United States are head and neck cancers. Although the incidence of this type of cancer is relatively low, survival rates are poor -- with about a 50 percent of patients surviving over the five-year period following diagnosis, according to John Lee, MD, FACS, Principal Investigator of the trial and a Sanford Clinic Ear, Nose and Throat specialist.
Lee’s early research led to the discovery that mice treated with the generic drug dichloroacetate (DCA) responded to cancer therapy 30 percent better. He has received approval from the Food and Drug Administration to begin a clinical trial with patients who are receiving treatment for head and neck cancer. The trial will be open to Sanford patients, and others nationwide.
“We are proud of and continue to encourage innovative clinical trials at Sanford that helps us further understand the molecular, cellular and genetic basis of cancer,” said David Pearce, PhD, Vice President, Sanford Research in Sioux Falls.
Dr. Lee, who was honored in 2010 by the American Cancer Society for his research, has been studying the link between the Human Papilloma Virus (HPV) and the development of head and neck cancers. His research team has tested the treatment of head and neck tumors in mice finding that factors that enhanced the immune system seemed to improve the rates of survival.
DCA is being used in several ongoing clinical trials nationwide after a recent publication showed potential improvement for this drug in animal studies. The drug, which has been used in human patients with metabolic disorders, inhibits an enzyme called pyruvate dehydrogenase kinase (PDK) which is involved in the metabolic pathways at the cellular level. PDK is over expressed in many types of cancer, including the head and neck cancer that is part of this new clinical trial. The trial will evaluate how altering cell metabolism will affect the outcome for participants.
Dr. Lee has developed a placebo-controlled research study (a study in which a percentage of participants take an inactive substance that looks the same as active medications). All participants will receive the standard treatment for head and neck cancer and will, in addition, receive either the placebo or the study drug. This study will be masked, meaning the participant, study doctor and study coordinator are blinded to what the participant is taking. Participants will be monitored closely during treatment by their cancer doctors and Sanford Research staff.
A total of 50 patients will be enrolled in the clinical trial. After an initial screening, some patients will receive DCA as an oral medication or through a gastrointestinal tube twice a day for eight weeks. Others will receive placebos over the same period. During that time, participants will be given treatments of Cisplatin (a chemotherapy drug) and undergo radiation therapy. The participants’ progress will be followed over five years.
The new trial will study not only the safety of delivering DCA during treatment, but also assess the local response rate, overall survival and relative toxicities for participants participating in the study. Researchers also hope to evaluate participants’ HPV status and immune response levels and correlate those findings as part of the trial. Participants will also be evaluated for differences in health-related quality of life.
About Sanford Cancer Center (Sioux Falls, SD)
As a leader in the field, Sanford Cancer Center offers a unique, full continuum of care with advanced state-of-the-art treatment methods while maintaining highly personalized care that focuses on the emotional, social and spiritual needs of cancer patients and their families. In keeping with a commitment to excellence, Sanford continues to expand its multidisciplinary approach to cancer care as well as develop its destination cancer center by adding physicians, services, technology and facilities. As one of only 30 sites in the nation in the National Cancer Institute's Community Cancer Centers Program (NCCCP), the level of care experienced by patients at Sanford Cancer Center is unmatched by any cancer program in our region. For more information about Sanford Cancer Center, please visit www.sanfordcancercare.org or call 605-328-8003.