The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with oral cavity and oropharyngeal cancers. The trials are investigating combination therapies, treatment toxicity, specialized adjuvant therapies, and proton therapy. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Phase I
Study Type: Phase I/interventional/single-group assignment
Study Title: A Phase I Trial of Vorinostat in the Treatment of Advanced Laryngeal, Hypopharyngeal, Nasopharyngeal, and Oropharyngeal Squamous Cell Carcinoma of the Head And Neck.
Study Sponsor and Collaborators: The Ohio State University Comprehensive Cancer Center, National Comprehensive Cancer Network
Purpose: To study the side effects and best dose of vorinostat when given together with cisplatin and radiation therapy in treating patients with stage III or stage IVa squamous cell cancer of the oropharynx which is either unresectable or borderline resectable
Primary Outcome Measures: Maximum tolerated dose of vorinostat in combination with concurrent chemoradiation therapy, the toxic effects of the combination of vorinostat and cisplatin using NCI CTCAE v. 40 [time frame: weekly during treatment; every 2 weeks for the first month after treatment completion; then every 4 weeks until day 153]
Principal Investigator: Theodoros Teknos, MD, The Ohio State University; 614-293-8074, ted.teknos@osumc.edu
ClinicalTrials.gov Identifier: NCT01064921
Study Type: Phase I/interventional/single-group assignment
Study Title: Evaluation of Diagnostic Aids for Detection and Diagnosis of Oral Cancer
Study Sponsor and Collaborators: MD Anderson Cancer Center, National Institutes of Health, William Marsh Rice University
Purpose: To find out if certain instruments/devices, such as wide-field fluorescence imaging point spectroscopy and/or brush cytology, can help health care providers find mouth cancer more quickly than a standard oral clinical exam
Primary Outcome Measures: Performance of the POS, PS2, and VELscope as Diagnostic Aid for Oral Cancer [time frame: 1 day]
Principal Investigator: Ann M. Gillenwater, MD, BA, MD Anderson; 713-792-6920
ClinicalTrials.gov Identifier: NCT02251639
Study Type: Phase I/II/Interventional/single-group assignment
Study Title: A Phase I/II Study of T- Cell Receptor Gene Therapy Targeting HPV-16 E6 for HPV-Associated Cancers
Study Sponsor and Collaborators: National Cancer Institute, National Institutes of Health Clinical Center
Purpose: To determine a safe number of white blood cells harvested from the respective patient modified with retrovirus to infuse and to see if these particular tumor-fighting cells (anti-HPV E6) can shrink tumors associated with HPV
Primary Outcome Measures: To determine the objective tumor response rate and duration in patients with metastatic or recurrent/refractory HPV-16+ cancers treated with autologous T cells expressing the E6 TCR plus aldesleukin [time frame: 4 years]
Principal Investigator: Christian S. Hinrichs, MD, National Cancer Institute; 301-496-4164, Christian_Hinrichs@mail.nih.gov
ClinicalTrials.gov Identifier: NCT02280811
Phase II
Study Type: Phase II/interventional/
parallel assigment
Study Title: A Phase II Window of Opportunity Trial With GSK1120212 in Surgically Resectable Oral Cavity Squamous Cell Cancer
Study Sponsor and Collaborators: Washington University School of Medicine, National Comprehensive Cancer Network
Purpose: To study how trametinib affects tumor cells in patients with oral cavity squamous cell carcinoma that can be removed by surgery
Primary Outcome Measures: To analyze tumor-specific changes in putative tumor-initiating cell populations as defined by cell surface CD44 and intracellular phospho-ERK1/2 staining after treatment with GSK1120212 [time frame: baseline and day 15]
Principal Investigator: Ravindra Uppaluri, MD, PhD, Washington University School of Medicine; 314-362-6599, uppalurir@ent.wustl.edu
ClinicalTrials.gov Identifier: NCT01553851
Phase III
Study Type: Phase III/interventional/parallel assignment
Study Title: Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (A.D.E.P.T.) Trial for Oropharynx Malignancy
Study Sponsor and Collaborators: Washington University School of Medicine
Purpose: To study the intensity of adjuvant therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes
Primary Outcome Measures: Disease-free survival [time frame: 2 years]
Principal Investigator: Bruce Haughey, MBChB, Washington University School of Medicine; 314-362-0365, haugheyb@ent.wustl.edu
ClinicalTrials.gov Identifier: NCT01687413
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov. ■
