928
Participants
Start Date
December 31, 2010
Primary Completion Date
May 15, 2020
Study Completion Date
December 4, 2020
LI
LI 400 IU (2.0mL total daily) 1.0 mL peritumoral, 1.0 mL perilymphatic 5x weekly x3 consecutive weeks administered as neoadjuvant therapy prior to SOC, (surgery followed by radiation or concurrent radiochemotherapy with cisplatin 100 mg/m\^2 intravenously x3) to determine if LI plus CIZ affects the 3-5 year overall survival.
Cyclophosphamide
Cyclophosphamide was administered IV bolus (one time only) at a dose of 300mg/m\^2 three days prior to beginning treatment with LI. Standard of care (SOC) for previously untreated squamous cell carcinoma of the head and neck is currently surgery followed by radiotherapy (60-70Gy in 30 to 35 fractions over 6 to 7 weeks) for higher risk subjects (subjects determined at surgery to have adverse features per the National Comprehensive Cancer Network (NCCN) guidelines, such as, positive surgical margins, 2 or more clinically positive nodes or extracapsular nodal spread, etc. that would pre-dispose them for higher risk of recurrence) radiotherapy is combined with concurrent chemotherapy (cisplatin 100mg/m\^2 intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.
Indomethacin
One 25mg capsule of indomethacin was self administered orally (BID) beginning on day one of LI treatment daily until the day before surgery.
Zinc
One capsule daily self administered beginning on day one of treatment with LI until one day before surgery
Surgery
Excise tumor and nodes
Cisplatin
Cisplatin was administered 100mg/m\^2 IV concurrent with radiotherapy. The chemotherapy agent (cisplatin 100mg/m\^2) was administered intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.
Radiotherapy
Total 60 to 70 Gy (2Gy per day) in 30 to 35 fractions over 6 to 7 weeks to subjects determined at surgery to be at lower risk for recurrence (per NCCN guidelines). For subjects determined at surgery to be at higher risk for recurrence due to having positive surgical margins, 2 or more clinically positive nodes or extracapsular nodal spread etc. (per NCCN guidelines), radiotherapy (as above) is combined with concurrent chemotherapy (cisplatin 100 mg/m\^2) intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.
National Taiwan Research Hospital, Chengshan
Shin-Kong Wu Ho-Su Memorial Hospital, Taipei
Linkou Branch Chang Gung Memorial Hospital, Guishan
China Medical University Hospital, Taichung
Changua Christian Hospital, Chang-hua
National Cheng Kung University Hospital, Taipei
Kaohsiung Branch Chang Gung Memorial Hospital, Niaosong
Buddhist Tzu Chi General Hospital, Hualien Branch, Hualien City
Semmelweis University, Budapest
University of Szeged Dept of Oral and Maxillofacial Surgery, Szeged
University of Pecs Institute of Oncotherapy, Pécs
HNO-Klinik der medizinischen Universitat Graz, Graz
Markusovsky Teaching Hospital, Szombathely
CH Dubrava, Zagreb
Clinical Hospital Center Zagreb Kispaticeva 12, Zagreb
KBC Sestre Milosrdnice, Zagreb
KBC Zagreb, Zagreb
National Cancer Institute Dept of Clinical Oncology & Radiotherapy, Colombo
Serbia Clinic for ENT and Maxillofacial Surgery, Belgrade
Clincal Center Serbia Clinic for Oral and Maxillofacial Surgery, Belgrade
Faculty of Dental Medicine Clinic for Maxillofacial Surgery, Belgrade
Military Medical Academy Clinic for Maxillofacial Surgery, Belgrade
Complejo Hospitalario Univ. de Santiago, Santiago de Compostela
Dept of Head and Neck Surgery School of Medical Sciences Univ. Sains, Kuantan
Clinic for Stomatology department for maxillofacial Surgery, Niš
Cherkasky Regional Oncological Dyspensary Dept. Head and Neck tumour, Cherkasy
Clinical center Vojvodina Clinic for ORL, Novi Sad
Clinical Centre Vojvodina Clinic for Maxillofacial Surgery, Novi Sad
Hospital Universitario de Princesa, Madrid
Hospital Universitario Ramon y Cajal, Madrid
Hospital Madrid North Universitaro de Sanchinnaro, Madrid
Medical College Of South Carolina MSC550, Charleston
CHC Osijek, Osijek
Szpital Specialistyczny im. Ludwika Rydgiera, Krakow
Rambam Health Care Campus, Sha‘ar Ha‘Aliya
General Hospital Dr. Josip Bencevic, Slavonski Brod
Ryazan Clinical oncology Dispensary, Ryazan
Khon Kaen University Dept of Otolaryngology, Nai Muang
Sumy Regional Clinical Oncology Dyspensary, Sumy
Taichung Veterans General Hospital, Taichung
University of Cincinnati Medical Center, Cincinnati
Consorsio Hospital General Universitario de valencia, Valencia
Henry Ford Health System Henry Ford Hospital, Detroit
Rabin Medical Center, Petah Tikva
Clinical Diagnostic Laboratory of Dnepropetrovsk Municipal Institution City Multidisciplinary Clinical Hospital No. 4, Dnipro
ICL 6 avenue Bourgogne CS30519, Vandœuvre-lès-Nancy
University Kabangsan Medical Center, Kuala Lumpur
Grigoriev Institute for Medical Radiology of National Academy of Medical Science of Ukraine Dept. of Remote, Combined Radiation and Complex Therapy, Kharkiv
Simmons Cancer Institute at Southern Illinois University, Springfield
Zaporiz'ka Regional Clinical Oncology Dispensary, Zaporiz'ka Oblast'
Clinical Centre University of Sarejevo Clinic for ENT, Sarajevo
Ospedale S.G. Moscati Santissima Annunziata, Taranto
Lviv State OncologyRegional treatment and Diagnostic Center, Lviv
National Tumor Institute of Italy, Naples
Donetsk Regional Antitumor Center, Donetsk
University Clinical Hospital Mostar, Mostar
VA Puget Sound Healthcare System & University of WA, Seattle
Blokhin Cancer Research Center, Moscow
N.N. Blokhin Russian Cancer Research Center, Moscow
Leningrad Regional Oncology Center, Saint Petersburg
Galaxy Cancer Center, Ghaziabad
Vitebsk Regional Oncology Dispensary, Vitebsk
N.N. Alexandrov Research Istitute of Oncology and Medical Radiology, Lyasny
Searoc Cancer Center, Jaipur
Kursk Regional Clinical Oncology Dispensary, Kursk
Tata Memorial Hospital, Mumbai
Curie Manavata Cancer Center, Mumbai
Government Medical College and Hospital, Aurangabad
Sujan Regional Cancer Hospital & Amravati Cancer Foundation, Amravati
Bibi General Hospital and Cancer Centre, Malkapet
Spital Clinic Judetean Mures, Târgu Mureş
Sverdlovsk Regional Cancer Center, Sverdlov
Meenakshi Mission Hospital and Research Centre, Madurai
V.N. Cancer Center G. Kuppuswamy Naidu Memorial Hospital, Coimbatore
Budget Institution of Healthcare of Omsk Region Clincal Oncology Dispensary, Omsk
Amrita Institute of Medical Sciences, Kochi
Regional Cancer Center, Kerola
Regional Institute of Oncology IASI, Iași
University Clinical Centre Tuzla, Trnovac
Clinical Center Banja Luka, Banja Luka
St. Josephs Healthcare Department of Surgery, Hamilton
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke
CHU de Quebec - L'Hotel Dieu de Quebec, Québec
University of Debrecen Medical and Health Scioence Centre, Debrecen
National institute of Oncology, Budapest
Wojewodzki Szpital Specjalistyczny im Kopernika, Lodz
Swietokrzyskie Centrum Onkologii, Kielce
Centrum Onkologi-Instytut im. Marie Sklodowskiej-Curie, Warsaw
Centrum Onkologii im. Prof. Lukaszcyka, Warsaw
ul. M. Sklodowskiej-Curie 24A, Bialystok
Samodzielny Publiczny Szpital Kliniczny Klinika Otolarryngologii I Onkologii Laryngologicznej, Lublin
Weilkopolskie Centrum Onkologii Klinika Chirurgii Glowy Szye Onkologii Laryngologiczne, Poznan
Uniwersitecki Szpital Kliniczny Klinika Otolaryngologii Chirugii Glowy i Szxyi, Wroclaw
Clinical Center Nis center for Oncology, Niš
Hospital Universitari Vall d'Hebron, Barcelona
Oncology Unit Teaching Hospital Karapitya, Galle
Acibadem University Maslak Hospital ENT Department, Istanbul
Kharkiv Regional Clinical Oncology Center Dept. Of Head and Neck Tumour, Kharkiv
Kiev City Clinical Oncology Center of the Main Health Care Dept of Kiev Day Hospital Radiotherapy Dept., Kiev
Kiev City Clinical Oncology Center of the Main Health Care Dept. of the Kiev Day Hospital, Kiev
Haceteppe University Dept of Otolaryngology - Head and Neck Surgery, Ankara
Aintree University Hospital, Liverpool
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Orient Europharma Co., Ltd.
INDUSTRY
CEL-SCI Corporation
INDUSTRY