Department of Otorhinolaryngology

Otorhinolaryngology

Clinical Trials and Research Studies

Clinical Trials
Other Research Studies

 

Clinical Trials

Pre-Malignant Studies

  1. ALA Photodynamic Therapy for Pre-Malignant Head and Neck Tumors**

    Principal Investigator: Dr. Harry Quon

    • We are researching better ways of treating premalignant (pre-cancerous) and in-situ (noninvasive) head and neck cancer. These lesions are usually very superficial (do not invade deeply) and can be removed with surgery. However, even after complete surgical removal, they often return or a new lesion may develop in a different area.

    • The purpose of this study is to test a new, investigational type of treatment, photodynamic therapy (PDT) using a photosensitizing agent, 5-aminolevulinic acid (Levulan®). Photodynamic therapy is a treatment in which a light-sensitive drug is given. It concentrates in the area where cancer cells or precancerous cells are located. The drug is activated by laser light, which then kills cancer cells and precancerous cells. Researchers want to study the effects of PDT on precancerous lesions and find out if it will prevent it from coming back (recurring).

    • Consent Form**

  2. Top ^

Metastatic Studies

  1. Detection of Recurrent or Metastatic Head and Neck Cancer Using Proteomics as a Novel Technique**

    Principal Investigator: Dr. Marcia Brose

    • Involves collecting blood specimens from patients with known metastatic/recurrent head and neck cancer AND matched non-cancer controls

    • The purpose of this research is to find better ways to detect and treat head and neck cancers. Research using blood is an important way to try to understand human diseases. Doctors and other medical scientists want to:

      1. find better ways to detect cancer early,

      2. determine how cancer spreads and resists current types of treatment, and

      3. treat patients who have cancer by understanding the above processes. To do these things, they need more information about the causes and behavior of cancer. Medical doctors therefore want to compare the study samples of cancer patients to study samples from people who have not been diagnosed with cancer.

    • Consent Form**

    Top ^

  2. Phase II Study of BAY 43-9006 in Patients with Metastatic Thyroid Cancer**

    Principal Investigator: Dr. Marcia Brose

    • Patients must have histologically confirmed thyroid cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective

    • The purpose of this research study is to:

      1. find out if BAY 43-9006 prevents the growth of tumors,

      2. find out how long one might benefit from treatment with BAY43-9006,

      3. find out what side effects this drug may cause, and

      4. measure the amount of BAY 43-9006 in the blood and see if "markers" can be found to help understand who might benefit from BAY 43-9006.

    • Consent Form**

    Top ^

  3. MRI and Infrared Spectroscopy Study in Patients with Nodal Metastases

    Principal Investigator: Dr. Harry Quon

  4. Top ^

Stage III/IV Studies

  1. Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine VS. Concomitant Radiation and Cisplatin in Patients with Advanced Head and Neck Cancer

    Principal Investigator: Dr. Harry Quon
    (Brochure)

    • Radiation Therapy and cisplatin (a chemotherapy drug) vs Radiation Therapy, cisplatin and tirapazamine (2 chemotherapy drugs)

    • Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx

    • Stage II/IV (excluding T1N1, T2N1 and metastatic disease)

    • > 18 years old

    • Resource Tip Sheet

    Top ^

  2. Phase II, Open-Label Trial of the Safety and Biological Effect of Pre-operative Peri-lymphatic Ultralow Dose IRX-2 (with Cyclophosphamide, Indomethacin, and Zinc) in Patients with Locally Advanced, Resectable Cancer of the Head and Neck

    Principal Investigator: Dr. Jason Newman

    • The purpose of this study is to see if patients with squamous cell carcinoma can be safely treated with the IRX-2 regimen and to obtain information to determine if patients benefit from treatment with IRX-2. IRX-2 contains certain substances called chemical messengers. IRX-2 is designed to help the body recognize and, hopefully, attack the tumor that is growing in the body.

    • Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx.

    • No prior treatment

    • Surgically resectable T3 or T4a primary tumor or any T with N2 or N3

    • 18 - 80 years old

    • Daily IRX injections for 10 days (Mon-Fri) followed by surgery

    • One low-dose cyclophosphamide infusion on the first day of injection (one dose of chemotherapy)

    Top ^

Recurrent Disease Studies

  1. Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinectic Profile of Proxinium in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck Who Have Received at Least One Prior Anti-Cancer Treatment Regimen for Recurrent Disease

    Principal Investigator: Dr. Jason Newman

    • The purpose of this study is to determine the safety, tolerability, and a recommended dose of the study drug Proxinium.

    • > 18 years old

    • Must have at least one accessible tumor for direct injection.

    • Must be unresectable Minimum of 4 weeks from previous anti-cancer treatment

    • Weekly injections until tumor gets worse, tumor resolves, or patient becomes ill of side effects

    Top ^

Skin Cancer Studies

  1. Phase II Study of ZD1839 in Patients with Squamous Cell Carcinoma of the Skin

    Principal Investigator: Dr. Bob Lustig

    • The purpose of this study is to evaluate the use of ZD1839, which is an investigational agent that can be given with surgery and/or radiation without causing severe side effects. The study will evaluate the feasibility of combining ZD 1839 with radiation and surgery in the treatment of advanced skin cancer. It will also investigate the side effects of this treatment. This research is being done because there is very little information available about the interaction of these treatments in patients with skin cancer and the current treatment of these skin cancers when they recur or are advanced has limited effectiveness.

    • Patients must have histologically or cytologically confirmed squamous cell carcinoma of the skin either locally advanced or recurrent with measurable disease.

    • Patients may have previous surgical intervention with residual or recurrent disease.

    • Age > 18 years

    • Tumors must be at least 2 cms in size or have muscle, bone, lymph node, or perineural involvement.

    • No prior chemotherapy or Radiation Therapy to the field

    Top ^

Surgical Studies

  1. A Pilot Study Assessing Surgical Exposure During Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using The Da Vinci ® Robotic Surgical System

    Principal Investigator: Dr. Gregory S. Weinstein

    • A research study assessing transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions. When compared to non-robotic assisted procedures in other studies, TORS has been shown to reduce blood loss, post-operative pain, and the risk of infection. It also required a shorter hospital stay and led to a faster recovery and return to normal daily activities. This is the first large patient study examining a robotics approach to transoral surgery.

    • Eligible participants must be at least 18 years old and present with indications for diagnostic and therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx. Exclusion criteria include unexplained fever and/or treated, active infection; pregnancy; previous head and neck surgery precluding transoral/robotic procedures, and the presence of medical conditions contraindicating general anesthesia or transoral surgical approaches.

    • For more information about the study, call 215-349-5390.

    Top ^

Research Studies

Audiology Studies

  1. Bilateral Benefit in Adult Users of the HiRes® 90K Bionic Ear System

    Principal Investigator: Dr. Michael Ruckenstein, Center for Implantable Hearing Devices

    • The HiResolution® Bionic Ear is a surgically implanted device designed to improve hearing and perception of speech to people with severe to profound hearing loss who obtain limited benefit from conventional hearing aids. Many users of one Bionic Ear achieve high levels of spoken word recognition when speech is presented in quiet. However, even the most successful users experience difficulty in the presence of competing sounds and are poor at identifying where sounds come from. These limitations may be overcome in part by providing an implant to both ears.

    • The purpose of this study is to investigate hearing benefit in adults who are implanted with two Bionic Ears. In addition, this study will compare the bilateral benefits of two different sound-processing software programs (conventional and HiRes®).

    • This clinical study is being conducted to look at the bilateral benefits of two Bionic Ears (one implant in each ear) and to look at the effect of two sound-processing methods on bilateral benefit. All software and instrumentation to be used in the study have been released for commercial use by the U.S. Food and Drug Administration (FDA).

    Top ^

  2. THE MED-EL EAS (Electric-Acoustic Stimulator) with COMBI 40+ Flex EAS (FS) Cochlear Implant System

    Principal Investigator: Dr. Michael Ruckenstein

    • The purpose of this study is to test the safety and efficacy of using an electric hearing device (cochlear implant) and an acoustic hearing device (hearing aid) in the same ear. This is called electric-acoustic stimulation. The MED-EL E.A.S. (Electric Acoustic Stimulator) is a device that has both electric and acoustic parts. The electric part is the MED-EL COMBI 40+ FlexEAS Cochlear Implant, and the acoustic part is the Oticon Adapto Hearing Aid.

    Top ^

Tissue Bank

  1. Establishment of a Head, Neck and Oral Disease Tissue, Blood and Saliva Bank

    Principal Investigator: Dr. Bert O'Malley

    • The purpose of this research study is intended to find better ways to detect, treat, and understand head, neck, and oral diseases. Research using tissue is an important way to try to understand human disease. Doctors and other medical research specialists want to:

      1. find better ways to detect head, neck, and oral disease early,

      2. to determine how disease spreads and can fail current types of treatment,

      3. to treat and if possible, cure patients with these diseases.

    Top ^

Sinus Studies

  1. An Open-Label Study of Azithromycin Pharmacokinetics in Sinus Mucosal Tissue and Plasma in Subjects With Chronic Rhinosinusitis Following a Single 2g Dose of Azithromycin Extended Release for Oral Suspension or Azithromycin 500mg Tablet Formulation Once Daily For a Maximum of Three Days

    Principal Investigators: Dr. James Palmer and Dr. Alex Chiu

    • The main purpose of this study is to determine the absorption and distribution of azithromycin in sinus mucosal tissue and blood in adult subjects after treatment with a single 2g oral dose of azithromycin extended release for oral suspension or oral azithromycin 500mg tablet once daily for three days for subjects with chronic rhinosinusitis undergoing endoscopic sinus surgery. Azithromycin, an antibiotic approved by the Food and Drug Administration (FDA), is indicated as the treatment of a variety of community acquired infections, including those of the respiratory tract. Treatment of infections in adult subjects is usually 1.0 to 1.5 grams administered over one to five days. Animal studies of infection have provided information suggesting that giving the azithromycin all at once may result in improved outcomes.

    Top ^

  2. Detection of Sinusitis by the Electronic Nose and/or Breath Collection System

    Principal Investigator: Dr. Erica Thaler

    • The purpose of this study is to determine if the electronic nose and/or Breath Collection System can detect any bacteria in your exhaled breath that may be causing your symptoms of sinusitis. If bacteria are present, antibiotic choice is made easier and faster.

    Top ^

  3. Contribution of Second Hand Tobacco Smoke to Sinusitis

    Principal Investigator: Dr. Noam Cohen

    • The purpose of this research study is intended to identify the prevalence of passive smoke exposure and active smoking in patients who meet the objective and subjective guidelines for chronic rhinosinusitis set forth by the Sinus and Allergy Health Partnership. Ultimately, this information may further define causes of chronic rhinosinusitis, and may result in new therapies for rhinosinusitis.

    Top ^

  4. Pathogenesis of Chronic Rhinosinusitis

    Principal Investigator: Dr. Noam Cohen

    • The purpose of this research study is intended to find better ways to treat chronic rhinosinusitis. Research using tissues is an important way to try to understand human disease. Using tissue obtained in this project we will investigate the pathogenesis of chronic rhinosinusits. Our hypothesis is that patients with chronic rhinosinusitis have alterations within the epithelium lining the sinonasal cavities or within the bone of the sinuses. The alterations may be one or a combination of anatomic, genetic, inflammatory, or infectious etiologies. Tissues taken from patients undergoing transseptal-transphenoidal hypophysectomy will serve as a non-chronic rhinosinusitis control source of sinus mucosa.

    Top ^

  5. Use of a novel antibiotic combination to combat multi-drug resistant bacteria in chronic sinusitis

    Principal Investigator: Dr. Alex Chiu

  6. Top ^

Other Studies

  1. Medialization vs. Reinnervation for Vocal Cord Paralysis

    • This is a NIH funded prospective randomized national multi-center trial of two types of surgical procedures used to treat unilateral vocal cord paralysis.  We are actively recruiting patients interested in treatment for hoarseness associated with vocal cord paralysis.

    • Smell and Taste Center

    • Audiology Research Lab

    Top ^