Department of Radiation Oncology

Clinical Research Head and Neck Cancers

Strategic Direction and Overarching Themes for the Service

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Description of Programs and Protocols within the Service

Title: A Phase II Trial of Protease Inhibitor, Nelfinavir (NFV), Given with Definitive, Concurrent Chemoradiotherapy (CTRT) in Patients with Locally-Advanced, Human Papilloma Virus (HPV) negative, Squamous Cell Carcinoma of the Head and Neck

Principal Investigator: Alexander Lin, M.D.
Coordinator: Dana Patsch 
Office: (215) 615-5645
UPCC#: 15313

This is a single arm, phase II study of nelfinavir (1250 mg given po bid) and concurrent chemoradiotherapy in locally advanced head and neck cancer. Locoregional control will be compared to published historical results. There will be a total of 28 patients enrolled on the study.

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Title: A Single-arm Phase II Study of Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) to the Regional Nodes for Advanced Stage, Human Papilloma Virus (HPV) Positive, Oropharyngeal Cancer

Principal Investigator: Alexander Lin, M.D.
Coordinator: Ashley Feriozzi 
Office: (215) 615-3272
UPCC#: 40313

This is a therapeutic, phase II study for patients who are diagnosed with advanced stage oropharynx cancer and are Human Papiloma Virus (HPV) positive. The treatment plan for this study is to treat patients with a post-operative course of radiation (proton or photon) to surrounding lymph nodes, but omit post-op RT to the primary resection bed. We believe that omitting the radiation treatment to the primary tumor bed after the removal of the tumor will reduce the risk of the side effect of tumor bed ulceration after radiation therapy, while having no significant impact on the patient’s risk of having the cancer recur in the primary tumor site.

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Title: A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck

Principal Investigator: Erin McMenamin, MSN, CRNP
Coordinator: Kristi Lelionis, MS, CCRP
Office: (215) 615-3273
UPCC#: 43313

The purpose of this study is to assess the efficacy of pregabalin in the management of mucositis pain in patients receiving radiotherapy to the head and neck. Eligible study subjects will be enrolled among those being treated for oropharyngeal cancer with definitive chemotherapy and radiation therapy (photons) to the head and neck in the Department of Radiation Oncology at the University of Pennsylvania.

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Title: A pilot, Single-Center Study of Quantitative HPV Serum or Plasma DNA as a Prognostic Marker in p16+/HPV+ Squamous Cell Carcinomas of the Oropharynx and Unknown Primary Head and Neck Cancers

Principal Investigator: Peter Ahn, M.D
Coordinator: Allison Schnader
Office: (215) 662-6418
UPCC#: 22313

This study examines levels of HPV in the blood of HPV+ head/neck cancer patients over time. Patients treated with any combination of surgery, chemotherapy, and radiation can be eligible for the study. Study procedures include blood draws before, during, and after treatment.

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Title: Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) with Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas

Principal Investigator: William Levin, M.D.
Coordinator: Dana Patsch
Office: (215) 615-5645
UPCC#: 4214

This is a Phase I/II study of pre-operative image guided IMPT (IG-IMPT) or IMRT with simultaneously integrated boost (SIB) to the high risk margin of retroperitoneal sarcoma. The phase I portion of this study will evaluate up to four dose levels of IGIMPT or IMRT with simultaneously integrated boost (SIB) to the high risk margin of retroperitoneal sarcoma. Once the maximum tolerated dose (MTD) is determined (Phase I), participants will be accrued to the Phase II treatment using the combination of IG-IMPT or IMRT with SIB to determine if there is a sufficient signal, with respect to local recurrence, to warrant pursuing a large phase IIR or phase III trial.

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Title: Retreatment of Recurrent Tumors Using Proton Radiotherapy

Principal Investigator: John P. Plastaras, M.D., Ph.D.
Coordinator: Kristi Lelionis, MS, CCRP
Office: (215) 615-3273
UPCC#: 23309

The purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies. The primary outcomes are feasibility and acute toxicity. The study is infeasible if patient cannot be given treatment. Patient is unable to tolerate 15% treatment. patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion. Acuite Toxicity is defined as any grade 4 toxicity observed within 90 days from the initiation of radiotherapy that is felt to be directly related to their proton treatment. Toxicities will be graded by NCI CTC Version 4.0. Patients will be stratified by treatment site (Head and Neck, Thorax, Abdomen, Pelvis, Extremities) and by treatment volume (low volume, high volume) for a total of 10 strata. This study will be done in two phases. In the first phase, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 90 days after the last patient in the initial phase has completed treatment in each strata and once feasibility has been verified.

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Title: Prospective Follow-Up of Outcomes in Patients Receiving Photodynamic Therapy for Neoplastic Diseases

Principal Investigator: Charles Simone, M.D.
Coordinator: Ashley Feriozzi
Office: (215) 615-3272
UPCC#: 06911

This is an observational study for subjects who are age 18 or older and will undergo Photodynamic Therapy (PDT) for a diagnosis of neoplastic disease under the direction of a Penn physician. The purpose of this study is to learn and understand more about how PDT works. To do this we need to study the experiences of patients who undergo PDT and examine things like tumor type, other medical conditions, other therapies and treatment results.

There are no interventions being performed and only medical record data will be collected. We will collect your name, medical record number, date of birth, date of initiation of specific therapies such as surgery, radiation or PDT. This information will not be disclosed to others outside of the study team. The entire study is anticipated to take 10 years. Asubject will be in the study until they inform us that they no longer wish to participate.

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Title: Assessing the Impact of Electronic Capture of Patient Reported Outcomes in Radiation Oncology

Principal Investigator: Lilie Lin, M.D.
Coordinator: Alisha Maity 
Office: (215) 662-6347
UPCC#: 24915

Potential study subjects must have breast cancer, lung cancer, head and neck cancer, or gynecologic cancer and be receiving definitive external beam radiotherapy. The goals of this study are (1) to assess the feasibility of weekly administration of site specific patient reported assessments using an electronic platform, (2) to assess the psychometric properties (validity, reliability, responsiveness to change, utility) of anatomic site specific patient version of the common terminology criteria for adverse events (PRO-CTCAE) item sets in measuring radiation induced toxicities, and (3) to explore the correlation between patient reported outcomes using the PRO-CTCAE vs. physician reported outcomes using CTCAEv4.0 and well as known dosimetric prognostic factors in patients with lung, breast, head and neck, or pelvic malignancies.

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Title: RADVAX: A Stratified Phase I Trial of Pembrolizumab with Hypofractionated Radiotherapy in Patients with Advanced and Metastatic Cancers

Principal Investigator: Amit Maity, M.D. Ph.D.
Coordinator: Dana Patsch
Office: (215) 615-5645
UPCC#: 40914

Phase I clinical trial of hypofractionated radiotherapy to an isolated index lesion in combination with the PD-1 inhibitor, Pembrolizumab in patients with metastatic cancers who have failed anti-PD-1 therapy (melanoma and NSCLC) and patients with metastatic cancers who have have progressed after at least one regimen of systemic therapy (breast, pancreas, and other).

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