Head and Neck Cancer Clinical Trials

At the Mount Sinai Head and Neck Cancer Research Program, our research activities encompass clinical, translational, and basic science investigations that are carefully designed using a multidisciplinary approach to determine the safest and most effective treatments in curing head and neck cancers and other illnesses. Below are our current clinical and research trials and studies.

Auditory Treatments

GCO #11-0614
Principal Investigator: Eric Smouha, MD
Study Personnel: Stanley Pelosi MD, James Bradley, Alice Huang
Research Coordinator: Leslie A. Waters-Martin

Treatment of Outcomes in Chronic Otitis
The purpose of this retrospective chart review is to show that patients undergoing canal wall reconstruction mastoidectomy have equivalent recurrence rates and less postoperative otorrhea than patients undergoing canal wall down mastoidectomy. Approximately 500 records from 5/1/05 and onward have been reviewed. Results show that this technique is favorable for patients with large mastoid cavities who are at increased risk of recurrence using standard canal wall up mastoidectomy.

GCO #12-0901
Principal Investigator: Eric Smouha, MD
Study Personnel: Lucas Parra PhD, Dovid Fein PhD

Combined Auditory and Transcranial Direct Current Stimulation for Treatment of Tinnitus
Tinnitus is the persistent ringing in the ears for which there is no reliable treatment options. Two exploratory treatment options involve compensatory auditory stimulation (CAS) and transcranial direct current stimulation (tDCS). The purpose of this pilot study is to explore the benefits of combining tailored CAS with tDCS. This study involves auditory stimulation (compensatory or non-compensatory and tDCS stimulation (active or sham) as well as questionnaires audiograms and Tinnitus Likeness Spectrum activity. Preliminary results show positive benefit for the use of tDCS.

Head and Neck Bio-Data Bank

GCO #13-1778
Principle Investigator: Brett Miles, DDS MD FACS
Co-PI: Eric Genden, MD

Head and Neck Bio-Data Bank
This study will collect comprehensive clinical data by the going through patient records and clinical questionnaires. The collected data will be maintained in the clinical database application eRAP (electronic research application portal). This clinical data will be then linked to the specimen banked by the Mount Sinai CIB (Cancer institute biorepository) in an effort to identify disease specific biomarkers predicative of cancer behavior and response to therapy. The specimen collection takes place under the Mount Sinai CIB (GCO # 06-0996). The CIB will bank excess fluid (blood saliva) and solid (Head and Neck tumor biopsy, normal mucosal biopsy) patient specimens collected at baseline, during cancer therapy, and at progression which is partly as per standard of care.

GCO #13-0391
Principle Investigator: Brett Miles, DDS MD FACS
Co-PI: Julio Aguirre-Ghiso, PhD
Study Personnel: Hailun Wang, MD

Dormancy Markers in Neck Specimens and Surgical Margins
Aim#1: To identify dormant tumor cells nodes in neck dissection specimens obtained from patients who underwent primary surgical resection through the use of a cytokeratin antibody. We will also characterize the surrounding microenvironment through staining with a TGF-2 antibody) Aim#2: To examine ipsilateral and contralateral neck dissection specimens in patients who recurred after undergoing primary radiation therapy to identify metastatic or disseminated tumor cell (solitary)-bearing nodes using the same methods as those in Aim #1.c) Aim#3: To examine primary tumor margins for markers associated with dormancy-inducing signaling pathways using NR2F1 & TGFb2 antibody staining.

Robotic Surgery for Oral Cancer

GCO #13-1411
Principle Investigator: Brett Miles, DDS MD FACS
Co- Investigators: Eric Genden, MD Marshall Posner, MD Marita Teng, MD Vishal Gupta, MD Kryzstoff Misiukiewicz, MD Richard Bakst Elizabeth Demicco, MD
Study Personnel: Michael Donovan, MD Yvonne Seenger, MD Sacha Gnjatic, PhD Rita Babu, RN
Clinical Research Coordinator: Phapichaya Chaoprang Herrera

(ADVAXIS) Window of Opportunity Trial of Neoadjuvant ADXS 11-001 Vaccination Prior to Robot -Assisted Resection of HPV-Positive Oropharyngeal Squamous Cell Carcinoma
This is an investigator-initiated prospective clinical study of patients with stage II-IV squamous cell carcinoma of the oropharynx (OPSCC) who are to undergo ablative transoral robotic surgery (TORS). We propose to test the hypothesis that the listeria-based HPV vaccine ADX11-001 induces circulating and tumor-infiltrating antigen-specific T cells in HPV16+ oropharyngeal cancer patients undergoing TORS resection. The results of this trial will assess the ability of ADX11-001 vaccination to induce a robust HPV-specific cytotoxic lymphocyte (CTL) response in the blood and tumor.

GCO#13-1662
Principle Investigator: Brett Miles, DDS MD FACS
Co-Investigators: Eric Genden, MD Marshall Posner, MD Marita Teng, MD Vishal Gupta, MD Kryzstoff Misiukiewicz, MD Richard Bakst Elizabeth Demicco, MD
Study Personnel: Michael Donovan, MD Yvonne Seenger, MD Sacha Gnjatic, PhD Rita Babu, RN
Clinical Research Coordinator: Phapichaya Chaoprang Herrera

Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal SCCA (SIRS)
This is a Non-randomized Phase II de-escalation clinical trial to establish recurrence rates, site of recurrence, survival and quality of life outcomes for early T-stage HPV positive oropharyngeal SCCA treated with upfront surgery. Eligible, consented and registered patients will undergo transoral robotic surgery and selective neck dissection. After pathologic evaluation, patients with early stage disease as defined below will be placed into surveillance protocol as outlined or assigned to adjuvant therapy, depending on risk factors. Patients with intermediate risk factors will receive postoperative radiotherapy alone (5000 cGy). Patients with poor prognostic features will receive concurrent chemoradiotherapy (5600 cGy) with weekly cisplatin. Patients taken off study (based on Section 9.2 “Criteria from Removal of Study”) will be followed for survival until the study ends. Any adverse events occurring thereafter in these patients will not be considered related to the study and will not be tracked or reported.

Sinus and Obstructed Sleep Apnea

GCO #13-0571
Principle Investigator: Satish Govindaraj, MD
Study Personnel: Yan Ho, MD

Characterizing Dendritic Cells in Sinonasal Tissue
The purpose of this study is to study the dendritic cells in patients with or without chronic rhinosinusitis. In this study we aim to collect sinonasal and lymphoid tissues from human subjects that are undergoing endoscopic/open sinus or skull base surgeries. Objectives: 1.To characterize the types of dendritic cells that are intrinsic to sinonasal tissues of normal human subjects as well as those with chronic rhinosinusitis with and without polyps. 2. To perform functional analysis of human dendritic cell subsets. 3. To compare the characteristics and distribution of human sinonasal dendritic cells with murine models in order to establish a mouse model for future studies on CRS."

GCO # 11-1718
Principle Investigator: Fred Lin, MD
Co-PI: Eric Genden, MD
Study Personnel: Hailun Wang, MD Erden Goljo, MD

Oncologic Therapy and the Development of Obstructive Sleep Apnea in the Head and Neck Patient
The primary purpose of the study is to determine the effect of radiation therapy on the development of clinically significant obstructive sleep apnea in the head and neck cancer patient.

GCO #11-1763
Principle Investigator: Fred Lin, MD
Co-PI: Eric Genden, MD

The Comparison of Tissue Coblation Versus Transoral Robotic (TORS) Tongue Base Resection in Obstructive Sleep Apnea Patients
The objective of the study is to compare the outcomes of utilizing transoral robotic surgery versus tissue coblation in performing tongue base reductions utilizing pre-and post-operative Epworth Sleepiness Scale and Apnea Hypopnea Index Scores. 20 Patients with sleep apnea from MSSM will be approached and consented; survey and CT scan will be performed. Subject will choose either Tongue base reduction surgery with tissue coblation or the surgery with Trans oral Robot. 4 months later a final survey will be administered.

GCO # 14-0462
Principle Investigator: Benjamin Malkin, MD
Co-PI: Satish Govindaraj, MD
Study Personnel: Arjun Parasher, MD

The Role of Doxycycline in Management of Severe Chronic Rhinosinusitis with Nasal Polyps
The purpose of this study is to test the safety and efficacy of Doxycycline in patients with Severe Chronic Rhinosiusitis with nasal polyps. Subjects will be randomized to either doxycycline or placebo in conjunction with standard of care medications--including oral steroids--for a treatment period of 20 days. The study team hopes to recruit recruitment goal is 90 subjects between Mount Sinai and Elmhurst Hospital. Study procedures involve routine otolaryngologic history and physical examination, blood draws allergy testing, CT scan, nasal cavity culture, and endoscopic nasal exam. The primary endpoint is the subjects' SNOT-22 score at 3 months. The PI has obtained an IND exemption from the FDA to do for this study.

Laryngopharyngeal Reflux Diagnosis

GCO #14-0673
Principle Investigator: Uchechukwu Megwalu, MD
Study Personnel: Nikita Gupta, MD

Evaluation of Laryngopharyngeal Reflux Diagnosis
To evaluate if laryngopharyngeal reflux (LPR) diagnosis using Reflux Symptoms Index and Reflux Funding Score improves LPR treatment outcomes. This retrospective chart review will take place at Queens Hospital Center Department of Otolaryngology. Outpatient electronic medical records will be reviewed from August 2011-August 2013. Diagnosis codes for gastroesophageal reflux and reflux esophagitis will be reviewed (approximately 200 records).

Honey for Local Wound Care

GCO # 13-1507
Principle Investigator: Joshua Rosenberg, MD
CO-PI: Eric Genden, MD
Study Personnel: Aldo Londino, MD

Role of Honey for Local Wound Care of Donor Sites after Split Thickness Skin Grafting
The purpose of this study is to examine to role of honey as a surgical dressing for head and neck reconstruction. Subjects enrolled in this study will be undergoing surgery to remove cancer within the head and neck region. Approximately 50-60 subjects will be enrolled in this study and will be randomized to either receive the honey dressing or standard of care.

Facial Nerve Disorders

GCO #13-1720
Principle Investigator: Joshua Rosenberg, MD
Co-PI: Eric Genden, MD
Study Personnel: Nikita Gupta, MD

Facial Nerve Disorders Database
The purpose of this study is to accrue data regarding treatment plans and outcomes in the treatment of facial nerve disorders. The research team plans to recruit 20 participants and study activities include collection of data about the participants' surgery outcomes.


Contact Us

Julio Aguirre-Ghiso, PhD
Director, Head and Neck Cancer Basic Research
Tel: 212-241-9582
Send e-mail

Brett A. Miles, DDS MD FACS
Assistant Professor
Head and Neck Oral and Maxillofacial Surgery
Oncology Microvascular Reconstructive Surgery
Tel: 212-241-2253

Leslie Waters-Martin
Research Program Coordinator
Tel: 212-241-7107

Advaxis Clinical Trial

Researchers at Mount Sinai are conducting a clinical trial testing a novel vaccine for patients with HPV-related oropharyngeal (tonsil and tongue base) cancer who are eligible to undergo robot-assisted surgery. Watch video

Helpful Resource

Head and Neck Study Criteria [PDF]