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Clinical Research Newsletter for Colleagues in the Community Clinical Research Newsletter for Colleagues in the Community Welcome to the Winter 2017 issue of the Stanford Cancer surgery, robotic surgery, stereotactic radiosurgery such as Institute Clinical Research Newsletter. This quarterly CyberKnife®, microvascular reconstruction, intraoperative publication is designed to inform our colleagues in the radiation therapy (IORT), along with new chemotherapy trials. medical community, and especially physicians who are The Stanford Cancer Institute Neuro-Oncology Program considering treatment options for their patients with offers Phase I through III trials as well as multidisciplinary, cancer, about current clinical trials available at the Stanford collaborative evaluation and treatment of patients with tumors Cancer Institute, a National Cancer Institute designated of the nervous system. This includes, but is not restricted Comprehensive Cancer Center. Many of these trials provide to; brain metastases, leptomeningeal cancer, glioblastomas access to novel therapies including new “targeted” agents, and less aggressive gliomas, benign brain and spinal tumors, often not available in the community. and base of brain neoplasms including pituitary disorders. As leaders of the Stanford Head and Neck Cancer Care Clinical trials have focused on vaccine therapy, antibody Program, we are delighted to introduce this edition of the therapy, novel chemotherapy agents, radiation sensitizers, newsletter, as it focuses on our Neuro-Oncology, Thoracic novel radiation therapy, and radiosurgery techniques. Oncology, and Developmental Therapeutics programs. The Developmental Therapeutics Program conducts Each of these programs offers cutting-edge clinical trials pharmacokinetic and pharmacodynamic driven first-in- for patients with tumors that can be challenging to treat human trials tailored to make early, informed decisions with current routine care. Weekly multidisciplinary tumor regarding the suitability of novel molecular agents for boards are available for each program. The articles on further clinical investigation. each program will introduce you to our programs, faculty We hope that you will consider referring your patients researchers, and currently available clinical trials. to Stanford for one of our many clinical trials. The Thoracic Oncology Program features a wide number of clinical trials for both early- and advanced- stage lung cancer, Chris Holsinger, MD Professor of Otolaryngology – Head and Neck Surgery including clinical trials focused on individualized treatment Director, Head and Neck Cancer Care Program based on the molecular characteristics of tumors, overcoming drug resistance, and employing immunotherapeutics. The program now offers interventional pulmonology (IP) modalities, Quynh Le, MD, FACR, FASTRO Katharine Dexter McCormick and Stanley McCormick including navigational bronchoscopy for biopsy of lung nodules. Memorial Professor and Professor, by courtesy, of IP is an emerging field that uses minimally invasive diagnostic Otolaryngology – Head and Neck Surgery and staging techniques for potential lung cancers. Dimitri Colevas, MD The Head and Neck Oncology Program’s research studies Professor of Medicine (Oncology) and, by courtesy, and protocols include treatment of intermediate and of Otolaryngology – Head and Neck Surgery advanced disease as well as hypoxia imaging. A breadth of treatment options are available including minimally invasive Stanford Head and Neck Program Renowned Faculty, Innovative Research, Pesonalized Patient-centered Care The Stanford Head & Neck Oncology Program (HNOP) • Robotic head and neck surgery, using transoral provides leading-edge multi-disciplinary, collaborative minimally invasive techniques to preserve speech and integrated treatment and evaluation for patients with and swallowing function. head and neck cancer. World-renowned specialists in each • Bench to bedside approaches such as a Phase 1 discipline (surgery, radiation oncology, medical oncology, dichloroacetate (DCA) study on modulating tumor and speech and swallowing rehabilitation) lead and cell metabolic activity. participate in both national and Stanford-initiated clinical • Pioneering laboratory research that demonstrated the trials. Physician and surgeon-scientists at Stanford bring the existence of “cancer stem cells” in HNSCC that correlated latest discoveries in basic and translational science to the with worse prognosis. bedside and clinic. • Identification of adult salivary gland stem cells and HNOP is a pioneer of major scientific their governing pathways that can be manipulated for breakthroughs that help patients through: preservation and/or restoration of salivary function from • Organ preservation approaches to head and neck cancer, radiation damage. using minimally invasive surgery and state-of-the-art • Collaboration with the Stanford Clinical Laboratory radiation. to harmonize biomarker measurement for biomarker • New drugs and immunotherapy for head and neck driven trials to test treatment intensification or de- squamous cell carcinoma (HNSCC) and innovative uses intensification such as the use of circulating EBV DNA of existing drugs to HNSCC. in nasopharyngeal carcinoma. • Advanced radiation therapy techniques that limit toxicity • Genetic sequencing to identify a key driver mutation in and improve outcomes. ameloblastoma, leading to a clinical trial targeting BRAF • A cutting edge method to synthesize novel tracers for in these tumors. hypoxia imaging. P/2 Clinical Research Newsletter CLINICAL TRIALS RECRUITMENT SPECIALIST 650.498.7061 cancer.stanford.edu/trials • Developing novel imaging approaches for intraoperative CURRENTLY OPEN SELECTED TRIALS assessment of tumor margins to maximize tumor Minimally Invasive Surgery (Transoral Robotic Surgery) resection and organ preservation. • Randomized Trial of Transoral Surgery Followed by • Collaboration with basic scientists to define the best Low-dose or Standard-dose IMRT in Resectable p16+ combination of immunotherapy in head and neck cancer. Oropharynx Cancer (ECOG3311) This national clinical trial evaluates whether or not minimally FEATURES AT THE HNOP INCLUDE invasive surgery can reduce the intensity of treatment for HPV- • Close working relationships with: associated throat cancer. — Neurosurgery, Interventional Radiology, and Chemotherapy, Radiation Therapy, and Chemoradiation Neuroradiology, which are critical for complex open and endonasal endoscopic skull base surgery. • A Phase 2 Study of Sequential and Concurrent — Endocrinology in the treatment of thyroid cancer. Chemoradiation for Patients with Advanced Nasopharyngeal Carcinoma (NPC) (ENT0025) — Dermatology and Cutaneous Oncology in the This protocol is for patients with high risk locally advanced NPC treatment of advanced skin cancers, including or metastatic disease at presentation who may benefit from an melanoma, basal cell carcinoma, and cutaneous initial approach of chemotherapy followed by chemoradiation. squamous cell carcinoma. PI: Dimitrios Colevas, MD • Leadership in the head and neck disease site committee • A Randomized Phase 2 Trial for Patients with p16 Positive, of the NRG Oncology Group to develop new nationwide Non-Smoking Associated, Locoregionally Advanced clinical trials in head and neck cancer. Oropharyngeal Cancer (NRGHN002) • Biomarker studies to identify novel circulating biomarkers This trial represents an innovative patient-specific approach for prognostication and post-treatment surveillance in to overall treatment reduction, by either using accelerated head and neck cancer. radiation techniques or lower chemotherapy doses for • Strong links to the Stanford Developmental Therapeutics patients with very good prognosis HPV related cancer. Program for testing new agents to treat cancer. PI: Quynh Le, MD • Provision of a full range of treatment options that include • A Randomized Study of Individualized Treatment for minimally invasive surgery, robotic surgery, stereotactic Nasopharyngeal Carcinoma Based on Epstein Barr Virus radiosurgery such as CyberKnife, microvascular (EBV) Deoxyribonucleic Acid (DNA) (NRGHN001) reconstruction, intraoperative radiation therapy (IORT), This trial, the largest ever conducted in NPC, will both and new chemotherapy trials. explore whether a patient specific biomarker can help select • Innovative research by physicians now at Stanford patients who will not benefit from adjuvant chemotherapy that demonstrates the utility of the Mobetron® for and whether an alternative chemotherapy will benefit intraoperative radiation therapy. patients at highest risk of relapse. Dr. Quynh Le is the • highlighted studies are Stanford investigator initiated WINTER 2017 P/3 Stanford Head and Neck Program, continued translational science co-chair and Dr. Dimitrios Colevas • Phase I, Open-label Study Evaluating the Safety and is the medical oncology co-chair of this collaborative Pharmacokinetics of Escalating Doses of Cetuximab- international trial. IRDye800 as an Optical Imaging Agent to Detect Cancer PI: Dimitrios Colevas, MD During Surgical Procedures (ENT0049) Advanced Disease The investigators are evaluating whether or not the use of the study drug along with the special camera will better • A Randomized Study of Topical Dilute Hypochlorite identify the cancer while patients are in the operating room. (Modified Dakin's Solution) Treatment for the Prevention of PI: Eben Rosenthal, MD; Dimitrios Colevas, MD Radiation Dermatitis in Head and Neck Cancer (ENT0042) PI: Wendy Hara, MD • Phase I, Open-label Study Evaluating
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