Head and Neck Cancer Clinical Trials

Thyroid

A Phase II Trial Using RAD001 for Patients with Radioiodine Refractory Thyroid Cancer
GCO #11-0258
Principal Investigator: Krzysztof Misiukiewicz, MD
Research Nurse: Patricia Strebel, RN
Coordinator: Nadia Camille

The objectives of this study are to obtain information about the effectiveness of RAD001 as first or second line treatment in patients with thyroid cancer that has shown evidence of disease progression. If promising activity is detected, larger subsequent studies can be designed based on this treatment method. For more information, contact Nadia at nadia.camille@mountsinai.org or 212-824-7063.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of E7080 in 131I-Refractory Differentiated Thyroid Cancer
GCO # 12-0007
Principal Investigator: Krzysztof Misiukiewicz, MD
Research Nurse: Patricia Strebel, RN
Coordinator: Rachel Abbott

This is a multicenter, randomized, double-blind, placebo controlled Phase 3 study to compare the progression-free survival and overall survival of subjects with 131I-refractory differentiated thyroid cancer (DTC) and radiographic evidence of disease progression within the prior 12 months, treated with E7080 24 mg by continuous once daily (QD) oral dosing versus placebo. For more information, contact Rachel at rachel.abbott@mssm.edu or 212-824-7337.

HPV-Related Cancer

HPV Oral Transmission Study in Partners Over Time (HOTSPOT)
GCO #10-1473
Principal Investigator: Marshall Posner, MD
Coordinator: Nadia Camille

This study collects data on personal life style, social habits, and demographics; samples of saliva and blood; and samples of tumor to study the transmission, biology and immunity of the subjects to HPV. Eligible patients are 18 years or older with incident oropharyngeal, laryngeal, or hypopharyngeal squamous cell cancer. Partners of enrolled patients who identifies as a spouse or sexual partner of an oropharyngeal case may also participate. For more information, contact Nadia at nadia.camille@mountsinai.org or 212-241-7063.

Biomarkers of Immune Function as Predictors of Head and Neck Squamous Cell Carcinoma (HNSCC) Response to Therapy
GCO #10-1219
Principal Investigator: Andrew Sikora, MD/PhD
Coordinator: Alexis Patsias, MD

This is a study of the immune response in patients with oropharyngeal cancer who undergo treatment with radiation or chemoradiation. We are testing the hypothesis that radiation-based therapy of oropharyngeal cancer is associated with activation of the endogenous HPV-specific immune response. In this study, we will collect blood at several time points before, during, and after treatment to monitor the immune response in patients with tumors positive and negative for HPV versus normal healthy volunteers. Eligible patients are 18 years or older and have biopsy-proven squamous cell carcinoma, Stage II-IV, of the oropharynx, with a treatment plan including radiation or chemo-radiation. For more information, contact Alexis at alexis.patsias@mssm.edu or 212-241-4282.

Imaging

A Prospective, Multicenter Study, to Evaluate the Efficacy and Safety of [18F]-ML-10, a PET Imaging Radiotracer, in Early Detection of Response of Non-Hematological Tumors to Concurrent Chemoradiotherapy (ApoSense).
GCO #10-0926
Principal Investigator: Lale Kostakoglu, MD
Coordinators: Yasir Qureshi and Lena Marra

This is a multicenter study to evaluate the efficacy and safety of [18F]-ML-10 in its ability to image apoptosis and predict treatment response of non-hematological tumors in patients treated with concurrent chemoradiotherapy.[18F]-ML-10 is a novel, low molecular-weight probe, rationally-designed for targeting cells undergoing apoptosis. Eligible patients are 18 years or older with newly diagnosed locally advanced squamous cell carcinoma of the head and neck, with a primary tumor size of >2. For more information, contact Yasir at yasir.qureshi@mountsinai.org or 212-241-2209 or Lena at lena.marra@mountsinai.org or 212-241-9369.

Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous cell Cancer
GCO #10-0982
Principal Investigator: Sharmila Anandasabapathy, MD
Coordinator: Josephine Mitcham

The overall objective of this multicenter study is to determine whether high-resolution-imaging during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (pre-cancerous) areas. We are conducting a clinical trial of a new high-resolution microendoscope (HRME) in high-risk subjects undergoing endoscopic screening for suspected squamous cell neoplasia in both the United States and northern China. Eligible patients are 18 years or older and are undergoing endoscopic screening for esophageal squamous cell neoplasia. For more information, contact Josephine at josephine.mitcham@mountsinai.org or 212-241-6293.

In Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
GCO #09-2057
Principal Investigator: Brett Miles, MD
Coordinator: Alexis Patsias

The overall objective of this study is to evaluate whether noninvasive fluorescence and reflectance imaging of the upper aerodigestive tract can help clinicians more accurately determine intraoperative margins during ablative cancer surgery. This is an in vivo study designed to evaluate the feasibility of using prototype optical imaging technology to enhance the discrimination between areas of noncancerous “normal” and cancerous mucosa. Eligible patients have biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx and are receiving surgical treatment. For more information, contact Alexis at alexis.patsias@mssm.edu or 212-241-4282.

Minimally Invasive Surgery

Transoral Robotic Surgery (TORS) vs. Non-Surgical Treatment for Oropharyngeal Cancer: A COST-UTILITY STUDY
GCO #11-1683
Principal Investigator: Eric Genden, MD
Research Resident/Fellow: John de Almeida, MD and Nate Villanueva
Coordinator: Nadia Camille

The objective of this study is to perform a rigorous cost-utility analysis of Transoral Robotic Surgery (TORS) compared to Chemoradiotherapy for early T-stage oropharyngeal squamous cell carcinoma. Eligible subjects are 18 years or older, cancer-free, and are non-physicians. For more information, contact Nadia at nadia.camille@mountsinai.org or 212-241-7063.

Transoral Robotic Surgery (TORS) vs. Non Surgical Treatment for Oropharyngeal Cancer: A Retrospective and Prospective Multi-Institutional Comparative Study
GCO #11-1428
Principal Investigator: Eric Genden, MD
Research Resident/Fellow: John de Almeida, MD and Nate Villanueva
Coordinator: Nadia Camille

The objectives of this study are to evaluate the oncologic and functional outcomes of Transoral Robotic Surgery (TORS) for oropharyngeal squamous cell carcinoma and to compare outcomes between TORS and chemoradiotherapy by means of a retrospective and prospective stage matched comparative study. Eligible subjects for the retrospective component are patients with resectable primary oropharyngeal squamous cell carcinoma (T1-T4), who were treated with TORS or conventional chemotherapy from January 1, 2006 to December 31, 2011. Eligible subjects for the prospective component are patients with primary oropharyngeal squamous cell carcinoma (T1-T4) that are considered within the indications for robotic surgical treatment or conventional chemotherapy and are treated sometime from January 1, 2012 to the closure of the study.

Chemotherapy and Targeted Therapy

Phase I Study of Cabazitaxel-PF Induction Chemotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
GCO #11-0646
Principal Investigator: Krzysztof Misiukiewicz, MD
Research Nurse: Patricia Strebel, RN
Coordinator: Nadia Camille

The objectives of this study are to assess the safety, the maximum tolerated dose (MTD) and the dose limiting toxicity of cabazitaxel when combined with cisplatin and FU induction chemotherapy, as well as to assess the best overall response rate after 3 cycles and the PFS and OS after 3 years. Eligible patients are 18 years or older with stage IV, previously untreated, locally advanced SCCHN (may have had previous surgery, but not chemotherapy or radiotherapy). For more information, contact Nadia at nadia.camille@mountsinai.org or 212-241-7063.

A Randomized, Double-Blind Phase II Safety Study of Cetuximab, Using IMClone Versus Boehringer Ingleheim Manufacturing Processes, in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First-Line Treatment of Patients With Locoregionally Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
GCO #11-0970
Principal Investigator: Krzysztof Misiukiewicz, MD
Research Nurse: Patricia Strebel, RN
Coordinator: Rachel Abbott

The objectives of this study are to prospectively compare the safety profiles of commercial cetuximab manufactured by ImClone (Arm A) and Boehringer Ingleheim (Arm B), in terms of individual all-grade toxicities occurring any time during the treatment period. This study also aims to assess the overall safety and investigate the pharmacokinetics of cetuximab, as well as estimate overall survival, progression-free survival, and overall tumor response rate for this treatment. Eligible patients are 18 years or older with locoregionally recurrent and/or metastatic squamous cell carcinoma of the head and neck who have not received previous chemotherapy in this setting. For more information, contact Rachel at rachel.abbott@mssm.edu or 212-824-7337.

A Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase 3 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination with Paclitaxel and Carboplatin versus the Chemotherapy Alone in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck who have Progressed on or after Prior Platinum-Based Chemotherapy
GCO #12-0282
Principal Investigator: Krzysztof Misiukiewicz, MD
Research Nurse: Patricia Strebel, RN
Coordinator: Lewis Winder

The objectives of this study are to compare the overall survival for the treatment regimens in the study population, compare Objective Response (Complete Response (CR) + Partial Response (PR)) rate and duration of response for the treatment, and compare the safety and tolerability of the treatment in the study population. For more information, contact Lewis at lewis.winder@mssm.edu or 212-824-7310.

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of ALD518 in the Reduction of Oral Mucositis in Subjects with Head and Neck Cancer Receiving Concomitant Chemotherapy and Radiotherapy
GCO #12-0276
Principal Investigator: Marcelo Bonomi, MD
Research Nurse: Patricia Strebel, RN
Coordinator: Rachel Abbott

The primary objective of the clinical trial is to evaluate the safety and efficacy of the study drug ALD518 in modifying the course of oral mucositis (OM) in subjects with head and neck cancer (HNC) receiving concurrent chemotherapy and radiotherapy (CRT). For more information, contact Rachel at rachel.abbott@mssm.edu or 212-824-7337.

An Open-label Phase 2 Study of ACE-041 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
GCO #12-0513
Principal Investigator: Marshall Posner, MD
Research Nurse: Patricia Strebel, RN
Coordinator: Lewis Winder

The primary objective of this study is to estimate the objective response rate (ORR) of ACE-041 in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The secondary objectives include evaluating the safety and tolerability of ACE-041, the pharmacokinetic (PK) profile of ACE-041, the progression free survival (PFS) and overall survival (OS), time to tumor progression (TTP), duration of response, and rate of disease control (ORR + stable disease [SD]). This study also seeks to explore association of the expression of ALK1 and/or other relevant markers in tumor tissue with tumor response and/or other assessments of clinical response. For more information, contact Lewis at lewis.winder@mssm.edu or 212-824-7310.

Quality of Life and Supportive Care

Social Support, Emotional Disclosure, and Adjustment to Head and Neck Cancer
GCO #09-0557
Principal Investigator: Hoda Badr, PhD
Coordinator: Chi Yeung

The purpose of this study is to examine factors that may affect the quality of life of and relationships of patients with head and neck cancer and their spouses/partners or family caregivers. The study involves completing questionnaires at different time points (e.g., before, after, and during treatment). Patients and their caregivers will each receive a small gift card ($10) each time they complete a questionnaire. Eligible patients are 18 years or older and are initiating radiation therapy or surgery for head and neck cancer, and have a spouse or significant other with whom he/she resides or can identify a family member that serves as his/her primary caregiver. For more information, contact Chi at 212-659-5542.

Improving Oral Health and Quality of Life After Oral Cancer: A Web-based Approach
GCO #11-0040
Principal Investigator: Dr. Hoda Badr
Coordinator: Chi Yeung

This study proposes a web-based intervention, called Computer Assisted Oral Health Rehabilitation and Support (CARES), which is guided by Self Determination Theory (SDT). Specific aims are to develop and evaluate the content of the CARES intervention, to evaluate the feasibility of the CARES prototype, and to pilot test the initial efficacy of CARES. For more information, contact Chi at 212-659-5542.

Oncologic Therapy and the Development of Obstructive Sleep Apnea in the Head and Neck Patient
GCO #11-1718
Study Type: Sleep Apnea
Principal Investigator: Fred Lin, MD

The purpose of this study will be to determine if current cancer treatments (surgery, chemotherapy, radiation or a combination) for head and neck cancer, has any effect on developing and worsening of obstructive sleep apnea (OSA) during and after the treatments. OSA is a often described by patients as being unable to breath during sleep, including snoring and breath holding. If not diagnosed properly, one may complain about inability for a good night’s sleep, poor attention, bad moods and can possibly lead to conditions such as high blood pressure. Knowing that you have OSA can also help your doctor recommend appropriate treatments, such as a breathing mask called continuous positive airway pressure (CPAP) or another surgery. For more information, contact Fred at fred.lin@mssm.edu.


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: 212-241-9144