758
Participants
Start Date
November 30, 2011
Primary Completion Date
September 21, 2016
Study Completion Date
September 21, 2016
NeuVax™ vaccine
E75 peptide acetate (HER2/neu p366-379) in WFI (1.5 mg/mL) mixed with 250 micrograms Leukine® (sargramostim, GM-CSF), will be administered in intradermal injections, in four divided doses (4 sites on upper thigh) once a month, for six consecutive months. At the end of the six months, NeuVax™ vaccine boosters will be given the same way once every six months for the next five times (totaling 36 months).
Leukine® (sargramostim, GM-CSF) and water for injection
Leukine® 250 micrograms in water for injection, will be administered in intradermal injections, in four divided doses (4 sites on upper thigh) once a month, for six consecutive months. At the end of the six months, boosters inoculations will be given the same way once every six months for the next five times (totaling 36 months).
Serdika, Sofia
Tsaritsa Yoanna - ISUL, Sofia
Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology, Miskolc
Central Onco Hospital, Plovdiv
Complex Oncology Center, Veliko Tarnovo, Veliko Tarnovo
Kaposi Mor County Teaching Hospital, Center for Clinical Oncology, Kaposvár
Sveta Marina, Varna
Fountain Medical Group, New York
Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum, Berlin
Eastchester Cancer Care Center, The Bronx
Comprehensive Pain Management, Syosset
APWI, Williamsville
University of Pittsburgh Medical Center (UPMC) Cancer Center, Pittsburgh
Conemaugh Memorial Hospital-Memorial Medical Center, Johnstown
J. Fred Stoner, MD, New Castle
Gettysburg Cancer Center, Hillsdale
Progressive Pain Solutions, Wind Gap
Center of Cancer and Blood Disorders (VEEDA network), Bethesda
Vinnytsia Regional Clinical Oncology Center, Vinnytsia
Virginia Cancer Specialists, Fairfax
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel
Kirovohrad Regional Oncology Center, Department of Mammology, Kirovohrad
Wake Forest Baptist Health, Winston-Salem
Brustzentrum Klinikum Bremen-Mitte gGmbH, Bremen
Cancer Treatment Centers of America, Newnan
Interventional Spine and Pain Management, Atlanta
Northeast Georgia Cancer Care, Athens
Rambam Health Care Campus, Haifa
Central Georgia Cancer Care, Macon
Cancer Specialists of North Florida (ICON), Jacksonville
MD Anderson Center-Orlando Health, Orlando
Innovative Medical Research of South Florida, Inc., Aventura
Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center, Fort Lauderdale
Florida Cancer Research Institute (Florida Cancer Care), Plantation
Florida Cancer Care, Plantation
H.Lee Moffitt Cancer Center and Research Institute, Tampa
Alabama Oncology, Bessemer
Universität Marburg, Marburg
Physicians Pain Specialists of Alabama, P.C., Mobile
Upper East Side Pain Medicine, P.C., New York
The West Clinic, Memphis
The West Clinic Comprehensive Breast Center, Germantown
James Graham Brown Cancer Center, University of Louisville, Louisville
Akron General Medical Center, Akron
Institut de Cancérologie de l'Ouest/René Gauducheau, Saint Herblain, Nantes Cedex
William Beaumont Hospital Cancer Center, Royal Oak
Advanced Physical Medicine, Saint Clair Shores
Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Münster
Michigan Interventional Pain Center, Brownstown
Glenn Saperstein, D.O., LLC, Saginaw
Physiatry Consultants, Bay City
Rabin Medical Centre, Petah Tikva
Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy, Dnipropetrovsk
Institut de Cancérologie de l'Ouest Siet Paul Papin, Angers
Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy, Kryvyi Rih
Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center, Milwaukee
Sheba Medical Centre, Tel Hasomer
Klinikum Mutterhaus der Borromaeerinnen, Trier
Chernivtsi Regional Clinical Oncology Center, Day Care Unit, Chernivtsi
St. Alexius Medical Center, Mid Dakota Clinic, PC, Bismarck
Centre Oscar Lambret, Cédex
Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe, Frankfurt
Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center, Chicago
State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine, Kharkiv
Kharkiv Regional Clinical Oncology Center, Day Care Unit, Kharkiv
Odesa Regional Clinical Hospital, Center for Mastology, Odesa
Pain Management Institute, Overland Park
Cancer Center of Kansas, Wichita
Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council, Zaporizhia
Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie, Heidelberg
Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik, Stuttgart
Mary Bird Perkins Cancer Center, Baton Rouge
Cancer Treatment Centers of America, Tulsa
PRIDE, Dallas
UT Southwestern Medical Center / Simmons Comprehensive Cancer Center, Dallas
Kaplan Medical Centre, Rehovot
Baylor College of Medicine, Houston
The University of Texas MD Anderson Cancer Center, Houston
University of Texas MD Anderson Cancer Center, Houston
Cancer Care Centers of South Texas, San Antonio
Clinical Trials of Texas, Inc, San Antonio
Brooke Army Medical Center (now SAMMC), Fort Sam Houston
Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy, Lviv
University of Colorado Cancer Center, Anschutz Medical Campus, Aurora
Red Rocks Center for Rehabilitation, Golden
Rotkreuzklinikum München gGmbH, Frauenklinik, München
Donetsk City Oncology Center, Donetsk
Donetsk Regional Antitumor Center, Oncosurgery Department #2, Donetsk
Pain Centers Nationwide, Peoria
Valley Pain Consultants, Scottsdale
Mariupol City Interdistrict Oncology Center, Surgery Department #2, Mariupol
Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy, Uzhhorod
University of Southern California/Norris Cancer Hospital, Los Angeles
Alexander Ford, MD, Los Angeles
Cancer Care Institute, Los Angeles
Pete J. Ruane, MD, Inc., Los Angeles
Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute, Los Angeles
Pain Institute of Santa Monica, Santa Monica
Randy Scharlach, MD, Woodland Hills
East Valley Hematology and Oncology Medical Group, Burbank
Coastal Pain Research, Carlsbad
Navajo Road Pain Management Center, El Cajon
Moores UC San Diego Cancer Center (UCSD), San Diego
Interventional Pain Management, Irvine
South Orange County Surgical Medical Group, Laguna Hills
St. Jude Medical Center, Virginia K. Crosson Cancer Center, Fullerton
California Cancer Associates for Research and Excellence, Inc., Fresno
California Cancer Associates For Research and Excellence, Fresno
University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center, San Francisco
Clinical Diagnostics Center, Simferopol
OHSU Knight Cancer Institute, Portland
Swedish Cancer Institute Research, Seattle
Multicare Health System-Research Institute, Tacoma
Weill Cornell Medical College, New York
N.N. Blokhin Russian Cancer Research Center, Moscow
N.N. Blokhin Russian Cancer Reserach Center, Moscow
Yaroslavl Regional Oncology Center, Yaroslavl
Ivanovo Regional Oncology Center, Ivanovo
Arkhangelsk Clinical Oncology Center, Arkhangelsk
Regional Clinical Oncology Center, Veliky Novgorod
Leningrad Regional Oncology Center, Saint Petersburg
St. Petersburg Clinical Hospital, Saint Petersburg
Mechnikov North-Western State Medical University, Saint Petersburg
Petrov Research Institute of Oncology, Saint Petersburg
Municipal Clinical Oncology Center, Saint Petersburg
"Oncology Center Sf. Nectarie, Department of Medical Oncology", Craiova
Oncomed SRL, Department of Medical Oncology, Timișoara
Orel Oncology Center, Oryol
Kursk Regional Clinical Oncology Center, Kursk
Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration, Krasnodar
Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration, Sochi
Pyatigorsk Oncology Center, Pyatigorsk
Medical Institution of Ryazan Region, Ryazan
Tambov Regional Clinical Oncology Center, Tambov
"Prof. Dr. Ion Chiricuta Institute of Oncology", Cluj-Napoca
Medisprof SRL, Department of Medical Oncology, Cluj-Napoca
Volgograd Regional Oncology Center #3, Volzhskiy
"Gavril Curteanu Municipal Clinical Hospital", Oradea
Republican Clinical Oncoogy Center, Kazan'
Dr. Constantin Opris County Emergency Hospital, Department of Oncology, Baia Mare, Maramures
Republican Oncology Center, Saransk
Samara Regional Clinical Oncology Center, Samara
Bashkir State Medical University, Ufa
Orenburg Regional Clinical Oncology Center, Orenburg
Clinical Diagnostics Center, Nizhny Novgorod
Nizhny Novgorod Regional Oncology Center, Nizhny Novgorod
Sverdlovsk Regional Oncology Center, Yekaterinburg
Research Institute of Oncology, Tomsk
Krasnoyarsk Kryzhanovsky Regional Oncology Center, Krasnoyarsk
Regional Oncology Center, Irkutsk
Iasi Regional Oncology Institute, Department of Medical Oncology, Iași
Western Connecticut Health Network, Danbury Hospital, Danbury
Stamford Hospital, Bennett Cancer Center, Stamford
Pain Management Associates of CT, PC, Stamford
Beth Israel Deaconess Medical Center, Boston
Lahey Clinic Department of Hematology and Oncology, Burlington
Jerrold Rosenberg, MD, Providence
Cross Cancer Institute, Edmonton
Health Sciences North Cancer Centre, Greater Sudbury
Ottawa Hospital Cancer Centre, Ottawa
Sunnybrook Research Institute, Toronto
Hospital Charles LeMorne, Greenfield Park
Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic, Brno
University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy, Hradec Králové
University Hospital Olomouc, Clinic of Oncology, Olomouc
General University Hospital in Prague, Clinic of Oncology, Prague
Centre Antoine Lacassagne, Nice
Universitätsklinikum Erlangen, Frauenklinik, Erlangen
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum, Essen
Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker, Würzburg
Hetenyi Geza Hospital, Department of Oncology, Szolnok
Szent Margit Hospital, V. Department of Internal Medicine, Oncology, Budapest
Semmelweis University, Department of Diagnostic Radiology and Oncotherapy, Budapest
Petz Aladar County Teaching Hospital, Center for Oncoradiology, Győr
Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy, Kamienskiego
Polish Red Cross Marine Hospital, Department of Chemotherapy, Gdynia
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy, Lodz
Greater Poland Cancer Center, Department of Chemotherapy, Poznan
Magodent, Warsaw
Non-Public Health Care Facility MAGODENT, Warsaw
Filantropia Clinical Hospital, Obstetrics and Gynaecology Department, Bucharest
Coltea Clinical Hospital, Oncology Department, Bucharest
Bucharest Universtiy Emergency Hosptial, Oncology Department, Bucharest
Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council, Kiev
Kyiv City Clinical Oncology Center, Department of Chemotherapy, Kyiv
Macclesfield District General Hospital, Macclesfield
The Christie NHS Foundation Trust, Withington
James Cook University Hospital, Middlesbrough
Plymouth Oncology Centre, Derriford Hospital, Plymouth
The Royal Marsden NHS Foundation Trust, Sutton
Leeds Teaching Hospitals Trust, St. James University Hospital, Leeds
Leicester Royal Infirmary, Leicester
The Royal Marsden NHS Foundation Trust, London
Academic Unit of Oncology, Nottingham University Hospital-City Campus, Nottingham
Weston Park Hospital, Sheffield
Southampton General Hospital, Southampton
University Hospital of North Staffordshire, Stoke-on-Trent
Lead Sponsor
Galena Biopharma, Inc.
INDUSTRY