Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
NCT ID: NCT01480479
Last Updated: 2018-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
745 participants
INTERVENTIONAL
2011-11-30
2016-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rindopepimut/GM-CSF plus Temozolomide
Rindopepimut (CDX-110) with GM-CSF
Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance.
Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.
Temozolomide
150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, or until intolerance or progression.
KLH plus Temozolomide
Temozolomide
150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, or until intolerance or progression.
KLH
Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8mL containing approximately 100mcg of KLH.
Interventions
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Rindopepimut (CDX-110) with GM-CSF
Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance.
Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.
Temozolomide
150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, or until intolerance or progression.
KLH
Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8mL containing approximately 100mcg of KLH.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Adult patients, ≥ 18 years old
2. Newly diagnosed glioblastoma
3. Attempted surgical resection followed by conventional chemoradiation
4. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory
5. No evidence of progressive disease from the post-operative period to the post-chemoradiation period
6. Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy
7. Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for at least 3 days prior to randomization
8. WHO-ECOG Performance Status ≤ 2
9. Patients of childbearing/reproductive potential will be instructed to use birth control as defined by your doctor.
Exclusion Criteria
1. Stereotactic biopsy only (without further surgical resection)
2. Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial disease.
3. History, presence, or suspicion of metastatic disease
4. Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide
5. Active systemic infection requiring treatment
6. History of any malignancy (other than glioblastoma) during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer, cured, early-stage prostate cancer in a patient with PSA level less than ULN,or other carcinoma in situ that has been adequately treated and cured.
7. Planned major surgery
8. Evidence of current drug or alcohol abuse
9. Known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to shellfish proteins
10. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with participating in a clinical trial
11. Women who are pregnant or lactating
18 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
St 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
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
Montefiore Medical Center
The Bronx, 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
Antwerp, , 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
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
Hospital Albert Einstein
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
CHUQ L'Hotel Dieu de Qujebec
Québec, Quebec, Canada
CHUS Hôpital Fleurimont
Shenbrooke, Quebec, Canada
Fundacion Santa Fe
Bogotá, Bogota D.C., Colombia
Hospital Ceske Budejovice
České Budějovice, , Czechia
Umiversity Hospital (Fakultni Nemocnice)
Prague, , Czechia
Hospital Na Homolce
Prague, , Czechia
Multiscan s.r.o.
Prague, , Czechia
Masaryk´s Hospital Usti nad Labem
Ústí 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
Saint-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
LMU Munich
Munich, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
NNA
Athens, Attica, 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
Pārel, 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.
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
SHEBA Medical Center
Tel Litwinsky, , Israel
UO Oncologie Medica Dipartimento Oncologico
Bologna, , Italy
Fondazione IRCCS Instituto Neurologico Carlo Besta
Milan, , Italy
Sacred Heart Catholic University
Rome, , Italy
Universita e AO Citta delia Scienza, Universita Di Torino
Torino, , Italy
Grupo Médico Camino S.C.
México, 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 City, , Mexico
Medisch Centrum Haaglanden
The Hague, South 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, Canton of Aargau, Switzerland
CHUV, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 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 City, , 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
Songkhlanagarind Hospital
Hat Yai, Changwat Songkhla, Thailand
Maharaj Nakorn Chiang Mai Hospital
Amphoe Muang, Chiang Mai, 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
Countries
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References
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Weller M, Butowski N, Tran DD, Recht LD, Lim M, Hirte H, Ashby L, Mechtler L, Goldlust SA, Iwamoto F, Drappatz J, O'Rourke DM, Wong M, Hamilton MG, Finocchiaro G, Perry J, Wick W, Green J, He Y, Turner CD, Yellin MJ, Keler T, Davis TA, Stupp R, Sampson JH; ACT IV trial investigators. Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1373-1385. doi: 10.1016/S1470-2045(17)30517-X. Epub 2017 Aug 23.
Seliger C, Oppong FB, Lefranc F, Chinot O, Stupp R, Nabors B, Gorlia T, Weller M; EORTC Brain Tumor Group. Association of antidepressant drug use with outcome of patients with glioblastoma. Int J Cancer. 2023 Apr 1;152(7):1348-1359. doi: 10.1002/ijc.34344. Epub 2022 Nov 17.
Other Identifiers
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CDX110-04
Identifier Type: -
Identifier Source: org_study_id
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