HOUSTON – (Nov. 30, 2018) – Hoping to increase the survival rate for oral cancer, doctors at The University of Texas Health Science Center at Houston (UTHealth) are participating in a multicenter, phase one/two clinical trial on a drug-releasing patch designed to shrink tumors prior to surgery.
“The holy grail of oral cancer care is to find a drug that makes it disappear permanently. We’re not there yet but the entire field is making remarkable progress,” said Simon Young, MD, PhD, DDS, assistant professor of oral and maxillofacial surgery at the School of Dentistry at UTHealth.
Oral squamous cell carcinoma is a particularly deadly form of cancer with an overall five-year survival rate of about 50 percent, according to multiple studies. In 2018, 51,540 people will get oral cavity and oropharyngeal cancer and an estimated 10,030 will die, reports the American Cancer Society. Alcohol and tobacco are risk factors, and treatment options include surgery, radiation, and chemotherapy.
In the clinical trial, doctors apply a postage stamp-sized patch containing a cancer-killing drug called cisplatin directly to the malignant growth. In all, 12 adhesive patches are applied and removed during office visits in the three weeks leading up to surgery.
Oral cancer occurs in the oral cavity (lips, inside the lips and cheeks, teeth, gums, the front two-thirds of the tongue and the floor and roof of the mouth) and in the oropharynx (middle region of the throat, including the tonsils and base of the tongue), according to the American Dental Association.
The patch could potentially reduce the risk of medication-associated side effects, Young said.
“Because only a small percent of the medication goes in the bloodstream, we can significantly increase the dosage at the site of the tumor,” said Young, holder of the Young Oral and Maxillofacial Surgery Research Professorship at the School of Dentistry.
Enrollment has begun and researchers hope to recruit about 30 patients. Some patients will receive 12 equal applications prior to surgery. Others will start the same treatment schedule but doctors may vary the dosage depending on their response.
Six months after surgery, doctors will compare patient outcomes and check for possible side effects, said Young, who sees patients at UT Dentists and is affiliated with Harris Health System and Memorial Hermann-Texas Medical Center. Young is on the faculty of The University of Texas MD Anderson Cancer Center UTHealth Graduate School of Biomedical Sciences.
Designed by Privo Technologies, the patch was engineered to deliver high concentrations of systemic agents within the primary tumor.
Approved by the Food and Drug Administration, the study is a combined safety and efficacy clinical trial. Enrollment criteria is on the ClincialTrials.gov website: https://clinicaltrials.gov/ct2/show/NCT03502148?term=simon+young&cond=cisplatin+oral+cancer&rank=1
Young’s collaborators at the School of Dentistry include assistant professor James Melville, DDS, and associate professor Jonathan Shum, MD, DDS.