Clinical Trials

Our team of physician-scientists, biologists, and researchers use a multidisciplinary approach to translational and clinical research. Our goal is to discover new insights into head and neck cancer biology and forge new treatment options, while providing a platform for rapid translation from bench to bedside. We are conducting clinical trials in a number of areas.

GCO# 13-1411
Principal Investigator:  
Brett Miles, DDS, MD, FACS
Study Coordinator: Pang Herrera
(ADVAXIS) Window of Opportunity Trial of Neoadjuvant ADXS 11-001
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
Principal Investigator:  Brett Miles, DDS, MD, FACS
Study Coordinator: Pang Herrera
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal SCCA (SIRS) Trial
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.

GCO# 14-2067
Principal Investigator: Richard Bakst, MD
Study Coordinator: Lynda Rath
Phase I Study of Afatinib with Postoperative Radiation Therapy for Intermediate and High Risk Squamous Cancer of the Head and Neck (SCCHN)
Open label, non-randomized, two arm two cohort Phase I dose-escalation study to determine the maximum tolerated dose (MTD) and tolerability of (1) afatinib with radiation therapy, and (2) afatinib with chemotherapy (docetaxel) and radiation therapy in the postoperative treatment of intermediate and high risk squamous cell carcinoma of the head and neck (SCCHN).

GCO# 09-0762
Principal Investigator: Richard Bakst, MD
Study Coordinator: Lynda Rath 
Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
To determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors; acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.

GCO# 12-1050
Principal investigator: Marshall Posner, MD
Study Coordinator: Amiya Vaz
The Quarterback trial: A randomized phase III clinical trial comparing reduced and standard radiation
Randomized phase III study comparing two doses of definitive radiation therapy given with induction and concurrent chemotherapy in HPV-positive oropharynx, unknown primary, or nasopharynx cancer. Eligible, consented, and registered patients will receive three cycles of Docetaxel Cisplatin and 5-FU (TPF) induction chemotherapy. After three cycles, the patients will be assessed for clinical, radiographic, and pathologic response to TPF. Patients with a clinical or radiographic CR or PR will be randomized on the second phase of this study, where patients with HPV 16 or with another strain of HPV will undergo a 2:1 randomization or 1:1 randomization, respectively, to reduced (5600 cGy) or standard (700 cGy) dose radiotherapy with weekly Carboplatin.

GCO# 13-1530
Principal Investigator: Krzysztof Misiukiewicz, MD
Study Coordinator: Amiya Vaz
A Phase Ib Dose Escalation/Randomized Phase II, Multicenter, Open-Label Study of BYL in Combination with Cetuximab
Mount Sinai is participating in the phase II portion of this study only. Cetuximab naïve patients will be enrolled in the randomized study (Scheme 1) to receive daily oral BYL719 in combination with weekly cetuximab (Arm 1) or weekly cetuximab alone (Arm 2) in cycles lasting 28 days. Patients in Arm 2 will be allowed to cross over to receive combination BYL719 and cetuximab treatment in a non-randomized Arm 2B upon progression of disease. Patients who cross over from Arm 2 to Arm 2B will receive a new baseline scan. Arm 3 (Scheme 2) will enroll non-cetuximab naïve patients for non-randomized combination treatment. Efficacy will be measured with radiological assessment and RECIST version 1.1 at 6, 12, 18 weeks from baseline, and every 8 weeks thereafter until disease progression. Using these two schemes, BYL719 will be assessed in combination with cetuximab for efficacy, safety and tolerability, and PK profile, in both cetuximab naïve and cetuximab resistant settings.

GCO 14-0343
Principal Investigator: Krzysztof Misiukiewicz, MD
Study coordinator: Amiya Vaz
A Randomized, Double-Blind, Placebo-Controlled Chemotherapy Plus Cetuximab in Combination with VTX-2337 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Comparing the safety and efficacy of SOC in combination with VTX-2337 to those treated with SOC plus placebo in subjects with recurrent or metastatic SCCHN. Efficacy objectives include comparing the PFS, OS, objective response rate (ORR), duration of best response (DOBR), disease control rate (DCR), and duration of disease control (DDC) of the two treatment groups. The PD of VTX-2337 will also be evaluated. This is a randomized, double-blind, placebo-controlled, parallel-group study. The study consists of screening (≤ 14 days), initial treatment (cycles 1-6), subsequent treatment (cycles 7+), and long-term follow-up. Following the screening period, qualified subjects will be randomized in a 1:1 ratio to receive SOC plus placebo or SOC plus VTX-2337. Randomization of all subjects will be stratified by receipt of prior systemic therapy of SCCHN, ECOG performance, and platinum therapy as assigned by the investigator at the time of randomization (cisplatin or carboplatin).

GCO# 15-0468
Principal Investigator: Brett Miles, MD
Study Coordinator: Enrique Perez
Application of Dermabond adhesive to reduce post-operative salivary leaks in head and neck surgery
Patients are followed for signs of a salivary leak until 3 months postoperatively or the initiation of any adjuvant cancer therapy such as radiation or chemotherapy, whichever comes first, following application of a synthetic tissue adhesive, Dermabond (2-octyl cyanoacrylate), to the re-approximated, sutured mucosal or skin surfaces of laryngectomies or pharyngectomies and intraoral free tissue reconstructions following surgery. In cases involving laryngectomies/pharyngectomies 2-octyl cyanoacrylate will be applied subcutaneously to the outer surface of new pharyngeal closures. In those involving intraoral reconstructions the adhesive will be applied intraorally to the sutured mucosal or skin surfaces.  Patients will also be monitored for other complications including infection, hematoma, and wound care requiring an extended hospital stays. As a comparison group, an archive of all the intraoral free flaps and laryngopharyngectomies performed at our institution for the period spanning the previous 5 years will be reviewed.

GCO# 14-0462
Principal Investigator: Benjamin Malkin, MD
Study Coordinator: Arjun Parasher, MD
The Role of Doxycycline in Management of Severe Chronic Rhinosinusitis with Nasal Polyps
Prospective, double-blind trial for patients with severe CRSwNP. Subjects will be randomized to either a treatment arm (doxycycline and standard therapy) or a control arm (placebo and standard therapy) for a 20-day treatment course. Standard therapy will consist of oral steroids and nasal saline sprays. Patients will be followed at 3-week, 8-week, and 12-week visits after the initiation of treatment. The primary endpoint will be change in Sino-Nasal Outcome Test (SNOT-22) at 12 weeks. Secondary endpoints will include change in endoscopic nasal polyp score, subjective symptom scores, radiographic changes seen on computerized tomography scan of the paranasal sinuses, changes in middle meatus cultures pre- and post-treatment, allergy association, need for surgical intervention, and number side effects and toxicities of doxycycline experienced by subjects.

GCO# 15-0955
Principal Investigator:  Marshall Posner, MD
Study Coordinator: Amiya Vaz
ADXS11-001 is Lm-LLO immunotherapy, developed for the treatment of HPV-associated cancers. ADXS11-001 is bioengineered to secrete an antigen-adjuvant fusion protein (tLLO-HPV-E7) consisting of a truncated fragment of the listeriolysin O (tLLO) fused to the full length E7 peptide of HPV-16. Because the vector is live attenuated bacteria, it is rapidly taken up by antigen presenting cells (APC) after intravenous (IV) administration. This Product: ADXS11-001/MEDI4736 7Protocol/Amendment No.: ADXS001-04/1 Version Date: 30 January 2015 Confidential Advaxis, Inc.  This causes activation of the APC and results in a multifactorial stimulation of innate immunity including triggering Lm-specific PAMP (pathogen-associated molecular patterns) receptors, DAMP (damage-associated molecular patterns) receptors, and TLRs (toll-like receptors). To the subject, this activation can manifest as flu-like symptoms or cytokine release symptoms that occur during or in the hours immediately following administration.

GCO# 14-0094
Principal Investigator: 
William Inabnet, MD, FACS
Research Assistant: Erin Bresnahan 
Adjuvant Selumetinib for Differentiated Thyroid Cancer Remission after Radioiodine
This is a double blind, randomized, placebo-controlled study comparing the efficacy of a short course (approximately 5-weeks) of selumetinib (75 mg, orally twice daily) with adjuvant RAI to placebo with RAI.

GCO# 15-0146
Principal investigator: Krzysztof Misiukiewicz
Study coordinator: TBD
Personalized Cancer therapy for Patients with Metastatic Medullary Thyroid Cancer (MTC)
This is a therapeutic clinical trial in which we will provide personalized therapy to patients with medullary thyroid cancer based on a Personalized Therapeutic Plan (PTP) developed under the separate Tumor Genomic Analysis and Molecular Testing for Personalized Cancer Therapy protocol. This therapeutic protocol applies only to the treatment period of Personalized Medicine. Our objective is to establish superiority of Personalized Medicine in terms of efficacy (Overall Response Rate) in MTC patients, or substantially similar efficacy but with reduced toxicity, when compared to the best standard of care option for recurrent/metastatic MTC (currently cabozantinib) as was demonstrated in a phase III trial.

Principal Investigator: 
Lale Kostakoglu, MD
Study Coordinator: Lena Marra
Integrated PET/MR Imaging after Primary Therapy of Head & Neck Malignancies
Prospective, single center study that will take place at The Mount Sinai Hospital. Primary endpoints have been determined to show integrated MRI-PET imaging will offer additional information to improve diagnostic accuracy over each technique alone and PET/CT. The primary clinical objective will assess the diagnostic performance of post-therapy FDG PET-MRI vs. FDG-PET and MRI alone vs PET/CT for restaging of locally advanced head and neck cancer patients as well as compare the false negative and false positive rates related to post-therapy changes between PET/MRI and PET/CT. Eligible subjects will undergo a standard of care PET/CT imaging study first.  The ordering physician may also order an MRI (with or without contrast) be done as part of clinical care. Subsequently, without injection of a second dose of F-18 FDG they will undergo a PET/MRI whole body imaging (PET/MRI device is located next door to the PET/CT suite at the Hess building).  

GCO# 13-1507
Principal Investigator: Joshua Rosenberg, MD   Benjamin Malkin, MD
Study Coordinator: Aldo Londino
Role of Honey for Local Wound Care of Donor Sites after Split thickness Skin Grafting
Examining the role of honey as a surgical dressing for FTT and STSG donor sites, hypothesizing that when compared to standard forms of local wound care, patients treated with honey impregnated gauze will heal faster with lower reported pain scores. The duration of enrollment will be for 6 months with a total of 9 months until completion of the primary analyses.

GCO# 13-0455
Principal Investigator: Peak Woo
Study Coordinator: Arjun Parasher, MD
Complications, Failures, and Diagnostic Challenges in Various Benign and Premalignant Laryngeal Lesions
Review of patients over the last 18 years with a diagnosis of recurrent respiratory papilloma, laryngeal varices, laryngeal scar, laryngeal nodules, laryngeal cysts, premalignant lesions of the larynx, laryngeal sarcoidosis, and vocal fold paresis. We will obtain information pertaining to method of diagnosis, diagnostic findings upon examination, treatment received, and outcomes. In laryngology, there is no standardization of nomenclature and diagnosis for pathology. Thus, this study strives to find specific diagnostic features of pathology in the larynx in order to standardize diagnosis by laryngologists. In addition, treatment and outcomes for each diagnosis will also be reviewed in order to establish success and failure rates after specific treatment options.

GCO# 14-0054
Principal investigator: 
Krzysztof Misiukiewicz
Study coordinator: TBD
Tumor Genomic Analysis and Molecular Testing for Personalized Cancer Therapy
Genomic analysis study with the purpose of identifying personalized target for therapy. The global primary endpoints for this study are to provide an adequate analysis of biopsied tissue, and identify personalized targetable treatments and are not specifically hypothesis driven.

GCO# 13-0391
Principal Investigator: Brett Miles
Study Coordinator: Hailun Wang, MD
Dormancy Markers
Identifying dormant tumor cell nodes in neck dissection specimens obtained from patients who underwent primary surgical resection through the use of a cytokeratin antibody. To examine ipsilateral and contralateral neck dissection specimens in patients who had recurrence after undergoing primary radiation therapy to identify metastatic or disseminated tumor cell (solitary) bearing nodes and examine primary tumor margins for markers associated with dormancy-inducing signaling pathways using NR2F1 & TGFb2 antibody staining.

GCO# 12-1641
Principal Investigator: 
Hoda Badr, PhD
Research Assistant: Krista Herbert
Improving Self-Management in Head and Neck Cancer
Patients treated with radiation (XRT) for head and neck cancers (HNCs) experience significant side effects such as abnormally reduced salivation, difficulty swallowing, and taste changes even after they have been definitively treated. To control side effects and minimize discomfort, intensive self-care protocols are prescribed, but adherence is poor. Partners (spouses/significant others) can play a critical role in supporting adherence, but often lack knowledge, experience high rates of distress, and display poor communication (e.g., critical or controlling), that can interfere with patient self-care. We have developed a home-based couples skills-training (CST) intervention that teaches: 1) self-management skills to control/prevent side-effects; 2) communication skills to facilitate coordination of care and support; and 3) strategies to improve communal coping and confidence in the ability to work as a team. The goal is to reduce healthcare utilization and improve multiple domains of patient and partner QOL.

  • Assess the feasibility/acceptability of a couples skills training (CST) intervention, using feedback from multidisciplinary team and individual interviews with stakeholders. Includes pilot testing six-session print and telephone counseling intervention.

GCO# 14-1432
Principal Investigator: Marita Teng, MD
Study Coordinator: Alok Saini, MD
The Effect of Psychological Distress of Hospital Length of Stay in Squamous Cell Carcinoma
Determining the prevalence of psychological distress in a subset of head and neck cancer patients we will screen all new patients in our head and neck cancer center using the Distress Thermometer and Problem List. Using a cutoff value of ≥ 4, we will identify those patients with psychological distress. We will then be able to determine the prevalence of psychological distress in patients with newly diagnosed SCC of the larynx, oropharynx, and oral cavity.  In addition we will determine the effect of psychological distress on hospital length of stay in patients with newly diagnosed squamous cell carcinoma. We will prospectively follow two cohorts of patients: those with a new diagnosis of SCC with psychological distress and those with a new diagnosis of SCC without psychological distress to determine the average length of stay for the performed procedures.

GCO# 11-0614
Principal Investigator: Eric Smouha, MD 
Study Coordinator: Stanley Pelosi MD, James Bradley, Alice Huang
Treatment of Outcomes in Chronic Ear Disease
Reveal 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.

Principal Investigator: Joshua Rosenberg, MD
Study Coordinator: Nikita Gupta, MD
Facial Nerve Disorders Database
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 that include collection of data about the participants' surgery outcomes.

GCO# 11-1762
Principal Investigator: Fred Lin, MD
Study Coordinator: Hailun Wang, MD
The Comparison of Tissue Coblation versus Trans Oral Robotic Tongue Base Resection in Obstructive Sleep Apnea Patients
Comparing 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 the School of Medicine 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. Four months later a final survey will be administered.

GCO # 11-1428
Principal Investigator: 
Eric Genden, MD
Study Coordinator: Pang Herrera
Transoral Robotic Surgery (TORS) vs. Non-Surgical Treatment for Oropharyngeal Cancer:  A Retrospective and Prospective Multi-institutional Comparative Study
In many institutions the standard of care for oropharyngeal, or oral, cancer is (chemo) radiotherapy.  This study will compare outcomes between these two treatment methods (TORS vs. non-surgical treatment) by means of a retrospective and prospective stage matched comparative study of outcomes,  hypothesizing that there will be no difference in oncologic outcomes between the two methods of treatment.

GCO# 05-0608
Principal Investigator: William Lawson, MD
Study Coordinator: Zachary Vandegriend, MD
Superior Rhinotomy Resection Bilateral Ethmoid Tumors
Retrospective chart review of all patients that have been treated by Dr. Lawson with a Superior Rhinotomy since 1999. All charts will be obtained from Dr. Lawson’s Office in the 5 East 98th Street ENT offices. All charts are housed in the clinic and if not they will be requested from the storage site. Also corresponding EPIC charts will be reviewed for data material as well.

GCO# 06-0996
Principal Investigator: Michael Donovan, PhD, MD
Study Coordinator: Lena Marra
The Mount Sinai Cancer Institute Bio-repository
Longitudinal observational study to establish a high quality tumor tissue and fluid repository that will support research to better understand the etiology of cancer including the processes governing cell replication and differentiation, and to develop cures for the disease.  Past Mount Sinai Hospital research has shown the majority of diagnoses and reflects the national hierarchy of site specific cancer morbidity demonstrating Mount Sinai’s commitment to quality patient care and the significance in establishing diversified tumor tissue and fluid resource such as the Mount Sinai Cancer Institute Biorepository (CIB) that will assist qualified scientists involved in translational research.