The Head and Neck Oncology Program at OSUCCC – James is at the forefront of the world’s efforts to improve outcomes of patients with head and neck malignancies. The program’s multidisciplinary team of experts—including medical oncologists, surgical oncologists, radiation oncologists, plastic surgeons and researchers—collaborates to improve the detection, treatment and rehabilitation of head and neck cancers. The team’s bench-to-bedside focus consistently offers patients newer, safer and more effective treatments as they are developed.
The Head and Neck Malignancies Clinical Research Program also benefits from National Cancer Institute (NCI) funding to the OSUCCC – James that supports the cost of conducting phase I and phase II clinical trials and facilitates the movement of promising phase II studies into phase III national trials.
Groundbreaking clinical research, supplemented by innovative translational science, is advancing treatment and prevention strategies and improving patient outcomes. Particular areas of clinical-research strength include:
- Breakthroughs in the association between human papillomavirus (HPV) and head and neck cancers that are changing how head and neck cancer trials are designed, with investigators stratifying patients by HPV status
- Improving cure rates for nasopharyngeal cancer
- Developing novel treatment approaches for anterior skull-base tumors and advanced-stage resectable mouth and throat cancers
- Developing new reconstructive surgical approaches for the throat, voice box and windpipe
- Using microarray technology to generate a tumor-specific gene expression profile for squamous cell carcinoma of the head and neck that identifies gene-specific causative and prognostic biomarkers for the disease
- Ohio State’s Center for Clinical and Translational Science
- Cranial Base Center
Clinical research for head and neck malignancies at the OSUCCC – James is supported by numerous grants, both private and public. Some notable examples:
Genetic and Signaling Pathways in Epithelial Thyroid Cancer (CA124570)
PI: Matthew Ringel, MD, co-director of the OSUCCC – James Thyroid Cancer Unit.
Objective: This five-year, $11.3 million, National Cancer Institute (NCI) Program Project Grant (PPG) is a renewal grant; the PPG was first awarded in 2008 at $11.9 million. The funding supports four interacting research projects and four core services.
- Genes in the Predisposition to Papillary Thyroid Carcinoma
- Genetic Alterations that Initiate Follicular Thyroid Carcinogenesis
- Selective Modulation of Thyroidal Radioiodine Accumulation
- P21-Activated Kinase in Thyroid Cancer
- Integrated Clinical Information and Pathology Sample Repository
- Mouse Imaging and Pathology
- Biostatistics and Data Integration
Thyroid cancer SPORE grant
PI: Matthew Ringel, MD
Objective: This five-year, $11.3 million, NCI, Specialized Program of Research Excellence (SPORE) grant (CA168505) is a collaboration with MD Anderson Cancer Center but based at Ohio State. The primary goal of the research is to improve the outcomes and lives of patients with thyroid cancer through early diagnosis and prediction of tumor behavior, minimizing treatment side effects and developing better treatment options for progressive disease.
Prevalence and Determinants of Oral HPV Infection in the U.S. Population (DE023175)
PI: Maura Gillison, MD, PhD
- Determine the prevalence and type distribution of oral HPV infection in the U.S. population;
- Identify demographic, behavioral and health factors independently associated with infection;
- Evaluate the distribution of factors associated with oral HPV infection and HNSCC (e.g., sexual behavior, tobacco use, alcohol use, marijuana use) by age, gender, race and birth cohort and compare these to incidence patterns for HPV-related and HPV-unrelated HNSCC in the U.S. population.
Examples of clinical trials for head and neck cancer that are under way at the OSUCCC – James.
OSU-07061: Transoral Robotic Surgery in Treating Patients with Benign or Malignant Tumors of the Head and Neck
PI: Enver Ozer, MD
NCT ID: NCT01473784
This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery.
- Determine the feasibility of TORS in patients with oral and laryngopharyngeal benign and malignant lesions.
- Assess the impact of TORS on intra-operative surgical outcomes such as operative time, blood loss and complications.
OSU-10056: Study of Papillomavirus in Teens and Twenties
PI: Maura Gillison, MD, PhD
NCT ID: NCT00994019
Objective: HPV is a recognized cause of some oropharyngeal (tonsil) cancer, but little is known about oral HPV infection and risk factors. This study evaluates the prevalence of oral HPV infection, the sexual behaviors associated with risk for infection and the duration of infection.
OSU-11124: Everolimus versus Placebo in Head and Neck Cancer
PI: Maura Gillison, MD, PhD
NCT ID: NCT01111058
Objective: Two-year progression-free survival in subjects treated with everolimus versus placebo after definitive local therapy.
RTOG-3501: TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer
PI: Maura Gillison, MD, PhD
NCT ID: NCT01711658
This trial is studying whether lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients with HPV-negative head and neck cancer.
- Progression-free survival.
- The time from randomization until development of distant metastasis.
- Adverse events through 17 months.
- Compliance with planned treatment.
OSU-09120: Phase I Trial of Vorinostat in the Treatment of Advanced Stage Oropharyngeal Squamous Cell Carcinoma
PI: Ted Teknos, MD
NCT ID: NCT01064921
This trial evaluates the side effects and optimal dose of vorinostat when given with cisplatin and radiation therapy in treating stage III or stage IVa squamous cell cancer of the oropharynx that is either unresectable or borderline resectable.
- Maximum tolerated dose of vorinostat in combination with concurrent chemoradiation therapy.
- Tumor responses to vorinostat or vorinostat combined with chemoradiation.
- Complete response rate overall and progression-free survival.
- Relationship between Vorinostat therapy and tumor suppressor genes product assessed by Fas and FasL protein expression level in tumor and the normal mucosa.
OSU-11010: A Phase I/II Trial of Cetuximab in Combination with Interleukin-12 Administered to Patients with Unresectable Primary or Recurrent Squamous Cell Carcinoma of the Head and Neck
PI: William Carson, III, MD
NCT ID: NCT01468896
- Determine the maximum tolerated dose of IL-12.
- Determine the proportion of patients who have a complete or partial response to treatment.
- Determine the proportion of patients who are progression-free.
Recent Clinical Research Accomplishments
Robotic surgery through the mouth is a safe way to remove tumors of the voice box. OSUCCC – James surgeons report that transoral robotic surgery for supraglottic tumors is safe and effective. The study found that robot-assisted surgery to remove these tumors through the mouth took about 25 minutes on average, with minimal blood loss—15.4 milliliters, on average, per patient. No surgical complications were encountered, and 11 of the 13 patients could accept an oral diet within 24 hours. Published in Head and Neck
Removing skull-base tumors through the nose and mouth. A procedure developed by OSUCCC – James head and neck cancer surgeons combines two complementary approaches—endoscopic endonasal surgery and minimally invasive robotic surgery—to treat tumors that are difficult to reach, including those considered inoperable. The surgeons access the base of the skull, intracranial cavity and top of the spine by operating through the nose and paranasal sinuses.
Translational Research Accomplishments
Medicated oral patch allows release of chemoprevention drug directly into precancerous oral lesions for an extended time. The study evaluated the drug fenretinide, a synthetic derivative of vitamin A that has highly promising anti-cancer properties but systemic therapeutic doses of the drug are toxic. This study used a new mucoadhesive patch invented by researchers at the OSUCCC – James led by OSUCCC – James researchers at Ohio State’s College of Dentistry, Susan Mallery, DDS, PhD, and at the University of Michigan. The oral patch allows targeted, controlled delivery of the drug delivery to oral tissue. Published in Pharmaceutical Research.
Oral HPV infection is three times more common in men than women. The study, led by OSUCCC – James medical oncologist and head and neck cancer specialist Maura Gillison, MD, PhD, helps explain why HPV-related oral cancers are three times more common in men than women. The findings will help develop strategies designed to prevent oropharyngeal cancer, a disease that is poised to overtake cervical cancer as the leading type of HPV-caused cancer in the United States. Published in the Journal of the American Medical Association
High levels of cancer stem cells do not necessarily mean a worse prognosis in head and neck cancer. The finding by OSUCCC – James researchers could have far-reaching implications for patient care. Cancer stem cells make up only a small percent of the malignant tumor cells, but they typically are resistant to chemotherapy and radiation, and those that survive treatment are thought responsible for tumor recurrence. It is therefore thought that tumors with high numbers of cancer stem cells are more likely to recur. These findings suggest that it is not the number of cancer stem cells present, but their sensitivity to therapy that matters. Published in the journal Cancer.
Researchers discover new mechanism by which HPV causes head and neck cancer and design a drug to block the mechanism. The new agent might offer a safer treatment for these tumors when combined with a tapered dose of standard chemotherapy, says principal investigator Quintin Pan, PhD. The findings might help meet the need for more effective and safer therapy for a growing number of HPV-positive head and neck cancers, which have tripled in incidence since the 1970s. Published in the journal Oncogene.