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Spots Global Cancer Trial Database for Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

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Trial Identification

Brief Title: Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

Official Title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

Study ID: NCT01480479

Study Description

Brief Summary: This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer. All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin. Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.

Detailed Description: The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug temozolomide can help improve the life expectancy of patients with newly diagnosed, resected EGFRvIII positive glioblastoma. The duration of participation in this study may be up to 5 years. After you are screened and enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF or KLH until either disease progression or intolerance to the medications. If your tumor progresses while on this study, your doctor may treat you with other therapies that are not part of the study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham, Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

University of Arizona Health Network, Tucson, Arizona, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

City of Hope Cancer Center, Duarte, California, United States

UC San Diego Moores Cancer Center, La Jolla, California, United States

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

Chao Family Comprehensive Cancer Center, Orange, California, United States

Kaiser Permanente, Redwood City Medical Center, Redwood City, California, United States

University of California, Davis, Sacramento, California, United States

University of California, San Francisco, San Francisco, California, United States

Stanford Cancer Institute, Stanford University, Stanford, California, United States

Hartford Hospital, Hartford, Connecticut, United States

Yale University Medical Center, New Haven, Connecticut, United States

Christiana Care Health Services, Newark, Delaware, United States

University of Florida, Gainesville, Florida, United States

Mount Sinai Medical Center, Comprehensive Cancer Center, Miami Beach, Florida, United States

MD Anderson Cancer Center Orlando, Orlando, Florida, United States

Tampa General Hospital, Tampa, Florida, United States

Atlanta Cancer Care, Atlanta, Georgia, United States

Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia, United States

Georgia Regents University, Augusta, Georgia, United States

Kaiser Permanente Hawaii Moanalua Medical Center, Honolulu, Hawaii, United States

Northwestern University Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States

Rush University Medical Center, Chicago, Illinois, United States

University of Chicago, Chicago, Illinois, United States

North Shore University Health System, Evanston, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

Covenant Clinic / Iowa Spine and Brain Institute, Waterloo, Iowa, United States

University of Kentucky, Lexington, Kentucky, United States

Norton Cancer Institute, Louisville, Kentucky, United States

Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States

LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, Louisiana, United States

Anne Arundel Medical Center, Annapolis, Maryland, United States

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Center for Cancer and Blood Disorders, PC, Bethesda, Maryland, United States

Dana-Farber Cancer Institute and Mass General Hospital, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States

University of Michigan Health System, Ann Arbor, Michigan, United States

Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center, Lansing, Michigan, United States

St. Mary's of Michigan Medical Center/Field Neurosciences Institute, Saginaw, Michigan, United States

Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute, Minneapolis, Minnesota, United States

Ellis Fischel Cancer Center, Columbia, Missouri, United States

Washington University in St. Louis, Saint Louis, Missouri, United States

Southeast Nebraska Cancer Center, Lincoln, Nebraska, United States

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States

New Jersey Neuroscience Institute, JFK Medical Center, Edison, New Jersey, United States

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

Monmouth Medical Center, Long Branch, New Jersey, United States

Dent Neurosciences Research Institute, Amherst, New York, United States

Montefiore Medical Center, Bronx, New York, United States

New York Methodist Hospital, Brooklyn, New York, United States

The Long Island Brain Tumor Center at Neurology Surgery, P.C., Great Neck, New York, United States

North Shore University Hospital, Manhasset, New York, United States

Columbia University Medical Center - The Neurologic Institute of New York, New York, New York, United States

Weill Cornell Medical College, New York, New York, United States

University of Rochester Medical Center, Rochester, New York, United States

SUNY Upstate Medical University, Syracuse, New York, United States

Brain and Spine Surgeons of New York, White Plains, New York, United States

The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, Durham, North Carolina, United States

Wake Forest Baptist Health, Winston-Salem, North Carolina, United States

University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States

University Hospitals, Case Medical Center (Cleveland), Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Ohio State University, Columbus, Ohio, United States

Providence Portland Medical Center, Oncology & Hematology Care, Portland, Oregon, United States

Pacific Neurosurgical, Portland, Oregon, United States

Lehigh Valley Physician Group-Hematology-Oncology Associates, Allentown, Pennsylvania, United States

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Temple University Hospital, Philadelphia, Pennsylvania, United States

West Penn. Allegheny Health System, Pittsburgh, Pennsylvania, United States

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

Medical University of South Carolina - Department of Neuroscience, Charleston, South Carolina, United States

University of Tennessee Medical Center - Knoxville, Knoxville, Tennessee, United States

Sarah Cannon Research Institute, Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Texas Oncology Midtwon, Austin, Texas, United States

Baylor Research Institute, Dallas, Texas, United States

The Methodist Neurological Institute, Houston, Texas, United States

University of Utah Department of Neurosurgery, Salt Lake City, Utah, United States

Fletcher Allen Health Care, Burlington, Vermont, United States

University of Virginia Healthcare System, Charlottesville, Virginia, United States

Swedish Neuroscience Institute, Seattle, Washington, United States

University of Washington Medical Center, Seattle, Washington, United States

University of Wisconsin Paul P Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Prince of Wales Hospital, Randwick, New South Wales, Australia

Royal North Shore Hospital, St Leonards, New South Wales, Australia

The Crown Princess Mary Cancer Centre, Westmead Hospital, Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital, Herston, Queensland, Australia

Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited, South Brisbane, Queensland, Australia

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Calvary North Adelaide Hospital, North Adelaide, South Australia, Australia

Royal Hobart Hospital, Hobart, Tasmania, Australia

Launceston General Hospital, Launceston, Tasmania, Australia

Monash Medical Centre, Clayton, Victoria, Australia

Austin Health, Heidelberg, Victoria, Australia

Epworth Healthcare, Richmond, Victoria, Australia

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia

Liverpool Hospital, Liverpool, , Australia

Medical University Innsbruck, Dept of Neurology, Anichstrabe 35, Innsbruck, , Austria

Medizinische Universität Wien, Innere Medizin I, Onkologie, Vienna, , Austria

Universitair Ziekenhuis Antwerpen, Edegem, Antwerp, Belgium

ZNA Middelheim, Antwerpen, , Belgium

Ghent University Hospital, Ghent, , Belgium

Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica, Porto Alegre, Rio Grande Do Sul, Brazil

Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho, Jaú, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de de São José do Rio Preto - Hospital de Base, São José do Rio Preto, São Paulo, Brazil

Instituto Nacional do Cancer (INCA), Rio de Janeiro, , Brazil

Hospital Albert Einstein, Sao Paulo, , Brazil

Instituto do Câncer do Estado de São Paulo - ICESP, São Paulo, , Brazil

Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José, São Paulo, , Brazil

Hospital A C Camargo, São Paulo, , Brazil

Foothills Hospital Medical Centre, Calgary, Alberta, Canada

British Columbia Cancer Agency, Vancouver Clinic, Vancouver, British Columbia, Canada

BC Cancer Agency - Vancouver Island Centre, Victoria, British Columbia, Canada

University of Manitoba-Cancer Care Manitoba, Winnipeg, Manitoba, Canada

QEII Health Sciences Centre, Halifax, Nova Scotia, Canada

Juravinski Cancer Centre, Hamilton, Ontario, Canada

London Regional Cancer Program, London Health Sciences Centre, London, Ontario, Canada

Ottawa Hospital, Regional Cancer Centre, Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame, Montreal, Quebec, Canada

Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada

CHUS Hôpital Fleurimont, Shenbrooke, Quebec, Canada

CHUQ L'Hotel Dieu de Qujebec, Quebec, , Canada

Fundacion Santa Fe, Bogota, Bogota D.C, Colombia

Hospital Ceske Budejovice, Ceske Budejovice, , Czechia

Umiversity Hospital (Fakultni Nemocnice), Prague, , Czechia

Hospital Na Homolce, Prague, , Czechia

Multiscan s.r.o., Praha 5, , Czechia

Masaryk´s Hospital Usti nad Labem, Usti nad Labem, , Czechia

Institut de Cancerologie de I'Quest-Paul Papin, Angers, , France

Institute Bergonie, Bordeaux, , France

Centre Leon Berard de Lyon, Lyon, , France

ICM Val d'Aurel Montpellier, Montpellier, , France

Institut de Cancerologie de L'Quest-Center Rane Gauducheau, Nantes, , France

Service de Neurologie-GH, Paris, , France

Centre Eugene Marquis, Rennes, , France

Institut de Cancerologie de l'ouest-Center Rene Gauducheau, St Herblain, , France

Institut Gustave Roussy, Villejuif, , France

Klinik und Poliklinik fur Neurologie der Universitat Regensburg, Regensburg, Bavaria, Germany

Strahlenklinik Universitatsklinikum Erlangen, Erlangen, , Germany

Dr. Senchkenbergisches Institut fur Neuroonkologie, Frankfurt, , Germany

University Hospital Hamburg Kopf und Neurozentrum, Hamburg, , Germany

Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672, Heidelberg, , Germany

University Medical Centre, Kiel, , Germany

Universitaetsklinikum Muenster, Muenster, , Germany

LMU Munich, Munich, , Germany

NNA, Athens, Attiki, Greece

"HYGEIA" Hospital, Marousi, District Of Attica, Greece

Országos Onkológiai Intézet Sugárterápiás Osztály, Budapest, , Hungary

Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet, Debrecen, , Hungary

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Sugárterápiás Osztály, Miskolc, , Hungary

Pécsi Tudományegyetem Általános Orvostudományi Kar, Pécs, , Hungary

Szegedi Tudományegyetem Onkoterápiás Klinika, Szeged, , Hungary

Vas Megyei Markusovszky Lajos Általános Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktatókórház Nonprofit Zrt, Szombathely, , Hungary

City Cancer Centre, Vijayawada, Vijayawada, Andhra Pradesh, India

HCG - Bangalore Institute of Oncology, Bangalore, Bengaluru, Karnataka, India

Amrita Institute of Medical Sciences and Research Centre, Kochi, Kochi, Kerala, India

Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, Thiruvananthapuram, Kerala, India

Marathwada Regional Cancer Centre and Research Institute - Government, Aurangabad, Maharashtra, India

Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri-West, Mumbai, India

Tata Memorial Hospital , Mumbai, Parel, Mumbai, India

Indraprastha Apollo Hospital, New Delhi, Jasola Viha, New Delhi, India

Sahyadri Hospitals Limited, Erandauame, Pune, India

Dr. Rai Memorial Medical Centre, Chennai, Chennai, Tamil Nadu, India

HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi, Delhi, , India

Soroka University M.C., Beer-Sheva, , Israel

Rambam Health Care Campus, Haifa, , Israel

Hadassah Medical Center, Jerusalem, , Israel

SHEBA Medical Center, Tel Hashomer, , Israel

Tel-Aviv Sourasky Medical Center, Tel-Aviv, , Israel

UO Oncologie Medica Dipartimento Oncologico, Bologna, , Italy

Fondazione IRCCS Instituto Neurologico Carlo Besta, Milano, , Italy

Sacred Heart Catholic University, Rome, , Italy

Universita e AO Citta delia Scienza, Universita Di Torino, Torino, , Italy

Grupo Médico Camino S.C., Mexico, D.F, Mexico

Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Jalisco, Mexico

Ensayos Clínicos y Medicina de Alta Especialidad, S.C., Culiacán, Sinaloa, Mexico

Servicios Medicos de Investigacion Clinica Sc, Durango, , Mexico

Hospital Central "Ignacio Morones Prieto", San Luis Potosí, , Mexico

Medisch Centrum Haaglanden, The Hague, Zuid Holland, Netherlands

VUMC, Amsterdam, , Netherlands

Radboud University Nijmegen Medical Center, Nijmegen, , Netherlands

Christchurch Hospital, Christchurch Central, Christchurch, New Zealand

Palmerston North Hospital, Roslyn, Palmerston North, New Zealand

Waikato Hospital, Regional Cancer Centre, Hamilton, Waikato District, New Zealand

Waikato Hospital, Regional Cancer Center, Hamilton, Waikato Distric, New Zealand

Hospital Almanzor Aguinaga Asenjo, Chiclayo, , Peru

Instituto Oncologico Miraflores, Lima, , Peru

Clinica Anglo Americana, Lima, , Peru

Clinica Ricardo Palma, Lima, , Peru

Oncosalud, Lima, , Peru

Institut Catala d Oncologia, LaHospitalet De Lubregat, Catalonia, Spain

Dra. Sonia Del Barco Berron, ICO Girona Avda,, Franca, Girona, Spain

Hospital Clinic, Barcelona, , Spain

ICO Badalona-Hospital Germans Trias i Pujol, Barcelonia, , Spain

Hospital 12 de Octubre, Madrid, , Spain

Kantonsspital Aarau Medizinische Onkologie Tellstrasse, Aarau, AG, Switzerland

CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, VD, Switzerland

Oncology Institute of Southern Switzerland (IOSI), Bellinzona, , Switzerland

Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse, Bern, , Switzerland

Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie, Geneva, , Switzerland

Brain Tumor Center, University Hospital Zurich, Zurich, , Switzerland

National Cheng Kung University Hospital, Tainan City, Bei District, Taiwan

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan

Chang Gung Memorial Hospital Linkou Branch, Taichung, , Taiwan

Taichung Veterans General Hospital, Taichung, , Taiwan

Chi Mei Medical Center, Tainan City - Yongkang District, , Taiwan

Tri-Service General Hospital, Taipei city - Neihu District, , Taiwan

Siriraj Hospital, Bangkoknoi, Bangkok, Thailand

King Chulalongkorn Memorial Hospital, Patumwan, Bankok, Thailand

Maharaj Nakorn Chiang Mai Hospital, Amphoe Muang, Chiang Mai, Thailand

Songkhlanagarind Hospital, Hat Yai, Songkla, Thailand

Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom

The Bristol Haematology and Oncology Centre, Bristol, , United Kingdom

Edinburgh Cancer Centre Western General Hospital, Edinburgh, , United Kingdom

Beatson West of Scotland Cancer Centrel, Glasgow, , United Kingdom

Guy's and St Thomas' NHS, Westminister Bridge Road, London, , United Kingdom

Nottingham City Hospital, Nottingham, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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