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New Clinical Research Study on Head and Neck Cancer

Sanford Research/USD is conducting a new clinical trial to study the safety and effectiveness of a drug treatment on patients receiving radiation and chemotherapy for head and neck cancer. John Lee, MD, FACS, Principal Investigator of the trial and Sanford Clinic Ear, Nose and Throat specialist, is leading the study that will evaluate how a drug that alters cell metabolism can affect the outcome for patients receiving treatment for head and neck cancers.

A common 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. About 50 percent of patients will survive over the five-year period following diagnosis. 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.

A new drug therapy

A team of basic researchers headed by Drs. Miskimins and Lee led early research to discover that mice treated with the generic drug dichloroacetate (DCA) responded to cancer therapy 30 percent better. They have 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. 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 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 patients.

The clinical trial

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 patients participating in the study. Researchers also hope to evaluate patients' HPV status and immune response levels and correlate those findings as part of the trial. Patients will also be evaluated for differences in health-related quality of life.

Posted Date: October 2011