Clinical Trials and Research Studies
Clinical Trials
Other Research Studies
Clinical Trials
Pre-Malignant Studies
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** Top ^
Metastatic Studies
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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:
find better ways to detect cancer early, determine how cancer spreads and resists current types of treatment, and 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 ^
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:
find out if BAY 43-9006 prevents the growth of tumors, find out how long one might benefit from treatment with BAY43-9006, find out what side effects this drug may cause, and 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 ^
MRI and Infrared Spectroscopy Study in Patients with Nodal Metastases
Principal Investigator:
Dr. Harry Quon Top ^
Stage III/IV Studies
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 ^
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
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
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
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
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 ^
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
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:
find better ways to detect head, neck, and oral disease early, to determine how disease spreads and can fail current types of treatment, to treat and if possible, cure patients with these diseases.
Top ^
Sinus Studies
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 ^
Detection of Sinusitis by the Electronic Nose and/or Breath Collection System
Principal Investigator:
Dr. Erica Thaler Top ^
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 ^
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 ^
Use of a novel antibiotic combination to combat multi-drug resistant bacteria in chronic
sinusitis
Principal Investigator:
Dr. Alex Chiu Top ^
Other Studies
Medialization vs. Reinnervation for Vocal Cord Paralysis Top ^
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