Head & Neck Cancer

Devraj Basu, MD, PhD

Head & Neck Cancer Specimen Bank

Specimen Bank

The research study is being done to collect samples from people with head and neck diseases such as cancer. We hope to use these samples to learn more about cancers and other diseases of the head and neck. This could lead to better ways to diagnose and treat these diseases. If you agree to join the study, you will be asked to complete the following research procedures:
1. Give up to 4 tablespoons of blood, 1 teaspoon of saliva (spit), and/or a stool sample.
2. Give some of the leftover tissue from your biopsy and/or surgery.
3. Let the researchers collect information about your health from your medical record.

Subject Population: Adults who had or are planning to have a biopsy or surgery

Duration of Subject Participation: About 1 hour

Contact: Dr. Devraj Basu (215) 349-5390 or Dr. Robert Brody (215) 662-2777 or Dr. Karthik Rajasekaran (215) 829-5180

Robert Brody, MD

Cohort Study of the Oncologic and Functional Outcomes of All Head and Neck Cancer Patients within the Health System of the University of Pennsylvania

Global H&N

This research is being done to understand the surgical, functional and oncological outcomes of all patients who underwent TORS as compared to other approaches for Head & Neck cancers. The eligible patients will be asked to complete a questionnaire.

Subject Population: Adults who have gone through treatment for HNC at University of Pennsylvania

Duration of Subject Participation: About 30 minutes

A Novel Application of Lymphangiography to Map Lymphatic Drainage Patterns in the Head and Neck

The research study is being done to see if an imaging method called “fluoroscopic lymphangiography” can help doctors to better treat patients with head and neck problems, including cancer.
If you agree to join the study, you will be asked to do the following:
1. Have a small amount of contrast dye injected into your tonsil before your planned surgery.
2. Have X-rays taken of your head and neck right before the surgery.

Subject Population: Adults who are planning to have surgery of the mouth or throat

Duration of Subject Participation: About 2 months

Contact: Dr. Christina Yver (215) 485-8713 Christina.Yver@pennmedicine.upenn.edu

Steven Cannady, MD

Functional Outcome Measures for Head & Neck Patients

Head and Neck Outcomes

This research study uses questionnaires to learn more about how people do after having treatment for head and neck cancer and reconstructive surgery. If you agree to join the study, you will be asked to fill out questionnaires before surgery and 3, 6, and 12 months after surgery.

Subject Population: Adults who are planning to have surgery for head and neck cancer

Duration of Subject Participation: About 1 year

Contact: Dr. Steven Cannady (215) 829-3000

Intraoperative & Post-operative Outcome Measures for an Osteomyocutaneous Variation on the Anterolateral Free Flap

ALTO

This research study uses questionnaires to learn about how pain and swallowing problems affect people’s day-to-day lives after surgery for head and neck cancer. If you agree to join the study, you will be asked to fill out questionnaires before surgery and 3, 6, and 12 months after surgery.

Subject Population: Adults who are planning to have surgery for head and neck cancer

Duration of Subject Participation: About 1 year

Contact: Dr. Steven Cannady (215) 829-3000

Post-Operative Measures for Patients Undergoing Reconstruction

This research study looks at how people do after having different types of head and neck reconstruction surgery. If you agree to join the study, you will be asked to let the researchers look in your medical record to collect information about your health.

Subject Population: Adults who are planning to have surgery for head and neck cancer

Duration of Subject Participation: About half an hour

Contact: Dr. Steven Cannady (215) 829-3000

The Association of Olfactory Dysfunction and Frailty in Head and Neck Cancer

This study is being done to look for links between frailty (being frail, or more likely to get sick) and the sense of smell. If you agree to join the study, you will be asked to complete the following research procedures:
1. Fill out surveys and take “scratch and sniff” smell tests during your regular doctor’s appointments before you begin head and neck cancer treatment, and at 3, 6, and 12 months after treatment.
2. Let the researchers collect information from your medical record.

Subject Population: Adults who have head and neck cancer

Duration of Subject Participation: About 1-2 years

Contact: Dr. Steven Cannady (215) 829-3000

Free Flap Outcomes after TORS

TORS Flaps (Free Flap Outcomes)

This is a retrospective chart review that aims to describe outcomes of microvascular free flap reconstruction in patients who have undergone TORS resection of advanced oropharyngeal cancer.

Subject Population: Adults who underwent free flap reconstruction following TORS resection of oropharyngeal cancer

Retrospective Review of the Financial Impact of Clinical Decisions in Head and Neck Cancer Surgery and Free Tissue Transfer Reconstruction

Financial Free Flaps

A retrospective review of the financial impact and costs associated with clinical decisions and patient care for patients undergoing head and neck cancer surgery as well as free tissue transfer for reconstruction.

A Multicenter Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair (RANGER)

RANGER

The research study is being done to collect information on the types on nerve injuries that have been repaired with the Avance® Nerve Graft, how it was used in patients, and what kind of recovery patients got after the nerve repair was made. This study will collect information about patients, like you, who have had nerve injuries repaired with the Avance® Nerve Graft. Meaningful findings will be shared with participating study doctors to help better understand and set recovery expectations around nerve repair for future patients implanted with the Avance® Nerve Graft.

Karthik Rajasekaran, MD

A Randomized Phase II Trial of Neoadjuvant and Adjuvant Therapy with the IRX-2 Regimen in Patients with Newly Diagnosed Stage II, III, or IVA SCC of the Oral Cavity

IRX-2

This is a randomized, multi-center, multi-national Phase 2b clinical trial of neoadjuvanty and adjuvant therapy with the IRX-2 regimen, intended for patients with diagnosed Stage III or IVA untreated Squamous Cell Carcinoma (SCC) of the oral cavity who are candidates for resection with curative intent. Subjects will be randomized 2:1 to either Regimen 1 or Regimen 2 and treated for 21 days prior to surgery and then postoperatively with a booster regimen given every 3 months for 1 year (a total of 4 times.)

Development and Validation of a Gene Expression Assay to Predict the Risk of Recurrence Disease in Cutaneous Squamous Cell Carcinoma

CBI cSCC (Castle)

Development and Validation of a Gene Expression Assay to Predict the Risk of Recurrence Disease in Cutaneous Squamous Cell Carcinoma (cSCC). Currently there is no prognostic molecular signature for cSCCs.  The goal of this study is to develop and validate a gene expression assay to predict recurrences of cSCC utilizing nucleic acid amplification and/or sequencing technologies as a stand alone test or in combination with clinicopathologic factors.

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician’s Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy, of Which at Least One Line Must Be Systemic Therapy

ASP-1929 Photoimmunotherapy

This study is being done to test if a new drug called ASP-1929 is safe and can help patients with head and neck cancer who have already tried other treatments that did not work. ASP-1929 is used together with an investigational device which lights up tumors, and may result in local destruction of tumors. Participants in this study will either have this investigational treatment or the current standard treatment, based on chance (like the flip of a coin). If you agree to join the study, you will be asked to do the following research procedures:
If you are placed in the Standard of Care group:
1. Have blood, urine, & heart tests; CT scans; and tumor biopsy, photos, & measurements.
2. Get standard anti-cancer medications through a vein in your arm, every 1-4 weeks.
If you are placed in the Experimental group:
1. Have blood, urine, & heart tests; CT scans; and tumor biopsy, photos, & measurements.
2. Get the investigational drug ASP-1929 through a vein in your arm.
3. The day after the ASP-1929 infusion: have light from an experimental device shined into your tumor(s). You may be put under anesthesia to help you sleep during this procedure.

Subject Population: Adults who have head and neck cancer

Duration of Subject Participation: About 3 years

Contact: Ellie Paul (215) 615-0410

A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients with Solid Tumors

CIVO

The research study is being done to look at the effects of injecting very small amounts of certain anti-cancer drugs directly into a tumor. If you agree to join the study, you will be asked to complete the following research procedures:
1. An ultrasound of your tumor area, if appropriate
2. An injection of a small amount of anti-cancer drugs into your tumor
3. Surgery per your standard care plan to remove your tumor

Subject Population: Adults who have head and neck cancer

Duration of Subject Participation: About 2 months

Contact: Eden Mikalic (215) 662-8762

Development and Validation of a Gene Expression Assay to Predict the Risk of Disease Progression in Oral Squamous Cell Carcinoma

Castle OSCC DevVal

This is a multi-center study with archival tissue. The purpose of the study is to develop a patient gene profile to better predict the potential of spreading the disease at different regions and overall progression of Oral cavity squamous cell carcinoma (OSCC) in patients.

Contact: Ellie Paul (215) 615-0410

ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery

Alume

The purpose of this research study is to assess the safety of an experimental agent (drug) called ALM-488, and to learn how well it shows nerve tissue in the body. If you decide to join the study, you will be asked to complete the following research procedures:
1. Have your vital signs measured, blood and urine samples taken, and do an ECG (EKG).
2. Receive the study drug on the day of your head and neck surgery.
3. Answer questions about how you are feeling 2 weeks and 4 weeks after the surgery.

Subject Population: Adults who are planning to have head and neck surgery

Duration of Subject Participation: About 1 month

Contact: Ellie Paul (215) 615-0410

Christopher Rassekh, M.D.

Clinicopathologic Evaluation of Chondrosarcoma and Chondroid Chordoma

Chondroid Chordoma

This study is designed to evaluate lesions of the skull base, particularly of the clivus and petroclival region which are classified as chondrosarcoma or chondroid chordoma. Patients with histologic diagnoses of these two entities will be identified from the pathology database and evaluated for calcification patterns.

Comprehensive Evaluation of Level I Neck Dissection, Part 1

Level I Neck

This study is designed to look at the outcome of neck dissection. The first phase of the study is to evaluate patients who have undergone neck dissection with the modified technique of level I dissection. The first phase will involve identifying patients who underwent staged neck dissection following Transoral Robotic Resection. The study involves a review of the medical records to determine the overall complication rate and node status of the neck dissections in these patients.

Robotic Surgery Outcomes for Parapharyngeal Space Tumor Removal

Parapharyngeal Space Outcomes I

Patients who have parapharyngeal space tumors removed via a transoral (Robotic) approach will be compared to those who underwent traditional open approaches: we will review the medical records of patients who underwent surgery for parapharyngeal space tumors for 1) surgical approach 2) pathology 3) radiology 4) surgical findings 5) complications.

Efficacy of Radiographically Enhanced Airway Clinical Tool for Prediction of Difficult Intubation and Surgical Exposure in TORS

REACT in TORS

We have designed a tool which includes clinical and radiographic parameters of airway measurement. These will be combined to determine if we can better predict situations when difficult intubation or surgical exposure will create clinical problems. We will obtain these measurements preoperatively in patients who will undergo Transoral Robotic Surgery and correlate them with Cormack and Lehane grade of intubation, percentage of glottic opening (POGO) score and degree of surgical exposure.

Retrospective Review of Sialoendoscopy Performed at HUP

Sialoendoscopy

This is a retrospective review of sialoendoscopy patients seen at UPHS since the clinic opened approximately 2 years ago. Patient characteristics, treatment modalities, clinical course, and follow-up will be reviewed and reported in the literature in a non-identifiable manner.

Surgical Outcomes for Parapharyngeal Space Tumor Removal: TORS vs Open vs Combined

Parapharyngeal Space Outcomes 2

This is a retrospective chart review study expanding on findings from a previous protocol (#814981). Patients who had parapharyngeal space tumors removed between Jan. 1, 2004, and March 22, 2016 via a transoral robotic (TORS) approach will be compared to those who had traditional open surgeries and to those who had combined (TORS + open) surgeries in that same time frame. We will focus on: 1) surgical approach 2) pathology 3) radiology 4) surgical findings 5) complications.

Prognostic Significance of Lymph Node Yield and Lymph Node Ratio in Patients Affected by Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, and Larynx: a Prospective, Multicenter, Observational Study

Lymph Nodes

The purpose of this study is to understand the course of Head and Neck Squamous Cell Carcinoma (HNSCC) in patients that may help doctors in better treating HNSCC. Eligible patients will be asked to provide medical information during their regular scheduled dosctor’s visit. Your participation in this study would last for up to 5 years.

Gregory Weinstein, M.D.

Retrospective Review of the Oncologic and Functional Outcomes of All TORS Patients

Retro TORS All

This is a review of the oncologic and functional outcomes of all patients who has undergone transoral robotic surgery (TORS) at the University of Pennsylavania.

E3311: Phase II Randomized Trial of Transoral Surgical Resection followed by Low-dose or Standard-dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

ECOG (E3311)

The incidence of base of tongue and tonsillar carcinomas has been increasing. The main hypothesis of this study is that TORS is feasible and effective in low- to intermediate-risk, HPV+ OPSCC patients. It is hypothesized that this permits pathologic-risk adjusted reduction in adjuvant therapy and radiotherapy treatment planning benefits and may be associated with favorable functional and QOL benefits without negatively impacting oncologic results. Targeted enrollment in 377 people in the U.S.