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Trial record 2 of 4 for:    Rindopepimut

Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma (ACT IV)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics
ClinicalTrials.gov Identifier:
NCT01480479
First received: November 21, 2011
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Glioblastoma
Small Cell Glioblastoma
Giant Cell Glioblastoma
Gliosarcoma
Glioblastoma With Oligodendroglial Component
Drug: Rindopepimut (CDX-110) with GM-CSF
Drug: Temozolomide
Drug: KLH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: During treatment and every three months from end of treatment through end of study or approximately up to 5 years. ] [ Designated as safety issue: No ]
    The primary efficacy endpoint of Overall Survival is defined as the number of months from randomization to the date of death (whatever the cause), and will be censored for patients who remain alive at completion of the study for patients with a gross total resection (~n=374). The overall survival of patients will be monitored and compared between the two study arms until the end of the study.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Every 12 weeks from Day 1 through progression or initiation of other anti-cancer therapy ] [ Designated as safety issue: No ]
    Compare progression-free survival between the two treatment arms

  • Safety and Tolerability [ Time Frame: Until day 28 of follow up ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be measured by comparing the two arms in regards to vital sign measurement, physical and neurological examination, adverse events reporting, ECOG performance status, and EORTC core Quality of Life Questionnaire


Estimated Enrollment: 700
Study Start Date: November 2011
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rindopepimut/GM-CSF plus Temozolomide Drug: 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.

Other Name: CDX-110 with sargramostim (GM-CSF) (Leukine®)
Drug: 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.
Other Names:
  • Temodar
  • Temodal
Active Comparator: KLH plus Temozolomide Drug: 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.
Other Names:
  • Temodar
  • Temodal
Drug: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria-

Among other criteria, patients must meet the following conditions to be eligible for the study:

  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-

Among other criteria, patients who meet the following conditions are NOT eligible for the study:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480479

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
United States, Arizona
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
University of Arizona Health Network
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope Cancer Center
Duarte, California, United States, 91010
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Kaiser Permanente, Redwood City Medical Center
Redwood City, California, United States, 94063
University of California, Davis
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94143
Stanford Cancer Institute, Stanford University
Stanford, California, United States, 94305
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Yale University Medical Center
New Haven, Connecticut, United States, 06520
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Mount Sinai Medical Center, Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta Cancer Care
Atlanta, Georgia, United States, 30005
Winship Cancer Institute, Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Hawaii
Kaiser Permanente Hawaii Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
North Shore University Health System
Evanston, Illinois, United States, 60201
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Iowa
Covenant Clinic / Iowa Spine and Brain Institute
Waterloo, Iowa, United States, 50702
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536-0093
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
LSU Health Sciences Center, Feist-Weiller Cancer Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21231
Center for Cancer and Blood Disorders, PC
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute and Mass General Hospital
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912
St. Mary's of Michigan Medical Center/Field Neurosciences Institute
Saginaw, Michigan, United States, 48604
United States, Minnesota
Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, Nebraska
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States, 68510
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
New Jersey Neuroscience Institute, JFK Medical Center
Edison, New Jersey, United States, 08818
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
United States, New York
Dent Neurosciences Research Institute
Amherst, New York, United States, 14226
Montefiore Medical Center
Bronx, New York, United States, 10467
New York Methodist Hospital
Brooklyn, New York, United States, 11215
The Long Island Brain Tumor Center at Neurology Surgery, P.C.
Great Neck, New York, United States, 11021
North Shore University Hospital
Manhasset, New York, United States, 11030-3186
Columbia University Medical Center - The Neurologic Institute of New York
New York, New York, United States, 10032
Weill Cornell Medical College
New York, New York, United States, 10065
University of Rochester Medical Center
Rochester, New York, United States, 14642
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Brain and Spine Surgeons of New York
White Plains, New York, United States, 10604
United States, North Carolina
The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
University Hospitals, Case Medical Center (Cleveland)
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Pacific Neurosurgical
Portland, Oregon, United States, 97227
Providence Portland Medical Center, Oncology & Hematology Care
Portland, Oregon, United States, 97213
United States, Pennsylvania
Lehigh Valley Physician Group-Hematology-Oncology Associates
Allentown, Pennsylvania, United States, 18103
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
West Penn. Allegheny Health System
Pittsburg, Pennsylvania, United States, 15212
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Medical University of South Carolina - Department of Neuroscience
Charleston, South Carolina, United States, 29425
United States, Tennessee
University of Tennessee Medical Center - Knoxville
Knoxville, Tennessee, United States, 37920
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology Midtwon
Austin, Texas, United States, 78705
Baylor Research Institute
Dallas, Texas, United States, 75246
The Methodist Neurological Institute
Houston, Texas, United States, 77030
United States, Utah
University of Utah Department of Neurosurgery
Salt Lake City, Utah, United States, 84112
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05405
United States, Virginia
University of Virginia Healthcare System
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Paul P Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2605
The Crown Princess Mary Cancer Centre, Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Calvary North Adelaide Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3199
Austin Health
Heidelberg, Victoria, Australia, 3084
Epworth Healthcare
Richmond, Victoria, Australia, 3121
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 06008
Australia
Liverpool Hospital
Liverpool, Australia, 2107
Austria
Medical University Innsbruck, Dept of Neurology, Anichstrabe 35
Innsbruck, Austria, 6020
Medizinische Universität Wien, Innere Medizin I, Onkologie
Vienna, Austria, 1090
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium, 2650
ZNA Middelheim
Antwerpen, Belgium, B-2020
Ghent University Hospital
Ghent, Belgium, 9000
Brazil
Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica
Porto Alegre, Rio Grande do Sul, Brazil, 90840-440
Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho
Jaú, São Paulo, Brazil, 17210-120
Fundação Faculdade Regional de Medicina de de São José do Rio Preto - Hospital de Base
São José do Rio Preto, São Paulo, Brazil, 15090-000
Instituto Nacional do Cancer (INCA)
Rio de Janeiro, Brazil, 20231-050
Hospital Albert Einstein
Sao Paulo, Brazil, 05652-900
Hospital A C Camargo
São Paulo, Brazil, 01509-900
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, Brazil, 01246-000
Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José
São Paulo, Brazil, 01321-001
Canada, Alberta
Foothills Hospital Medical Centre
Calgary, Alberta, Canada, T3J 5N6
Canada, British Columbia
British Columbia Cancer Agency, Vancouver Clinic
Vancouver, British Columbia, Canada, V5Z 4E6
BC Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada, V8X 4V6
Canada, Manitoba
University of Manitoba-Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E0V9
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital, Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A 2B4
CHUS Hôpital Fleurimont
Shenbrooke, Quebec, Canada, J1H5N4
Canada
CHUQ L'Hotel Dieu de Qujebec
Quebec, Canada, G1R 2J6
Colombia
Fundacion Santa Fe
Bogota, Bogota D.C, Colombia, 000
Czech Republic
Hospital Ceske Budejovice
Ceske Budejovice, Czech Republic, 370 01
Hospital Na Homolce
Prague, Czech Republic, 150 30
Umiversity Hospital (Fakultni Nemocnice)
Prague, Czech Republic, 150 06
Multiscan s.r.o.
Praha 5, Czech Republic, 155-00
Masaryk´s Hospital Usti nad Labem
Usti nad Labem, Czech Republic, 401-13
France
Institut de Cancerologie de I'Quest-Paul Papin
Angers, France, 49933
Institute Bergonie
Bordeaux, France, 33076
Centre Leon Berard de Lyon
Lyon, France, 69373
ICM Val d'Aurel Montpellier
Montpellier, France, 342298
Institut de Cancerologie de L'Quest-Center Rane Gauducheau
Nantes, France, 44805
Service de Neurologie-GH
Paris, France, 75013
Centre Eugene Marquis
Rennes, France, 35042
Institut de Cancerologie de l'ouest-Center Rene Gauducheau
St Herblain, France, 44805
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Klinik und Poliklinik fur Neurologie der Universitat Regensburg
Regensburg, Bavaria, Germany, 93053
Strahlenklinik Universitatsklinikum Erlangen
Erlangen, Germany, D-91054
Dr. Senchkenbergisches Institut fur Neuroonkologie
Frankfurt, Germany, D-60528
University Hospital Hamburg Kopf und Neurozentrum
Hamburg, Germany, 20246
Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672
Heidelberg, Germany, 69120
University Medical Centre
Kiel, Germany, 24105
Universitaetsklinikum Muenster
Muenster, Germany, 48149
LMU Munich
Munich, Germany, D-81377
Greece
NNA
Athens, Attiki, Greece, 11521
"HYGEIA" Hospital
Marousi, District of Attica, Greece, 151 23
Hungary
Országos Onkológiai Intézet Sugárterápiás Osztály
Budapest, Hungary, 1122
Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet
Debrecen, Hungary, 4032
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Sugárterápiás Osztály
Miskolc, Hungary, 3526
Pécsi Tudományegyetem Általános Orvostudományi Kar
Pécs, Hungary, 7624
Szegedi Tudományegyetem Onkoterápiás Klinika
Szeged, Hungary, 6720
Vas Megyei Markusovszky Lajos Általános Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktatókórház Nonprofit Zrt
Szombathely, Hungary, 9700
India
City Cancer Centre, Vijayawada
Vijayawada, Andhra Pradesh, India, 520002
HCG - Bangalore Institute of Oncology, Bangalore
Bengaluru, Karnataka, India, 560027
Amrita Institute of Medical Sciences and Research Centre, Kochi
Kochi, Kerala, India, 682 026
Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram
Thiruvananthapuram, Kerala, India, 695 011
Marathwada Regional Cancer Centre and Research Institute - Government
Aurangabad, Maharashtra, India, 431001
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Andheri-West, Mumbai, India, 400 053
Tata Memorial Hospital , Mumbai
Parel, Mumbai, India, 400012
Indraprastha Apollo Hospital, New Delhi
Jasola Viha, New Delhi, India, 110076
Sahyadri Hospitals Limited
Erandauame, Pune, India, 411004
Dr. Rai Memorial Medical Centre, Chennai
Chennai, Tamil Nadu, India, 600018
HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi
Delhi, India, 110092
Israel
Soroka University M.C.
Beer-Sheva, Israel, 84101
Rambam Health Care Campus
Haifa, Israel, 3109601
Hadassah Medical Center
Jerusalem, Israel, 91120
SHEBA Medical Center
Tel Hashomer, Israel, 52126
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Italy
UO Oncologie Medica Dipartimento Oncologico
Bologna, Italy, 40139
Fondazione IRCCS Instituto Neurologico Carlo Besta
Milano, Italy, 20133
Sacred Heart Catholic University
Rome, Italy, 00168
Universita e AO Citta delia Scienza, Universita Di Torino
Torino, Italy, 10126
Mexico
Grupo Médico Camino S.C.
Mexico, D.F, Mexico, 03310
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico, 34000
Ensayos Clínicos y Medicina de Alta Especialidad, S.C.
Culiacán, Sinaloa, Mexico, 80020
Servicios Medicos de Investigacion Clinica Sc
Durango, Mexico, 34000
Hospital Central "Ignacio Morones Prieto"
San Luis Potosí, Mexico, 78240
Netherlands
Medisch Centrum Haaglanden
The Hague, Zuid Holland, Netherlands, 2512 VA
VUMC
Amsterdam, Netherlands, 1081HV
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6525 GA
New Zealand
Christchurch Hospital
Christchurch Central, Christchurch, New Zealand, 8011
Palmerston North Hospital
Roslyn, Palmerston North, New Zealand, 4414
Waikato Hospital, Regional Cancer Centre
Hamilton, Waikato District, New Zealand, 3240
Waikato Hospital, Regional Cancer Center
Hamilton, Waikato Distric, New Zealand, 3240
Peru
Hospital Almanzor Aguinaga Asenjo
Chiclayo, Peru
Clinica Anglo Americana
Lima, Peru, Lima 27
Clinica Ricardo Palma
Lima, Peru, Lima 27
Instituto Oncologico Miraflores
Lima, Peru, Lima 18
Oncosalud
Lima, Peru, Lima 41
Spain
Institut Catala d Oncologia
LaHospitalet de Lubregat, Catalonia, Spain, 08908
Dra. Sonia Del Barco Berron, ICO Girona Avda,
Franca, Girona, Spain, 17007
Hospital Clinic
Barcelona, Spain, 8036
ICO Badalona-Hospital Germans Trias i Pujol
Barcelonia, Spain, 08916
Hospital 12 de Octubre
Madrid, Spain, 28041
Switzerland
Kantonsspital Aarau Medizinische Onkologie Tellstrasse
Aarau, AG, Switzerland, 5001
CHUV, Centre Hospitalier Universitaire Vaudois
Lausanne, VD, Switzerland, 1011
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland, 6500
Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse
Bern, Switzerland, 3010
Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie
Geneva, Switzerland, 1211
Brain Tumor Center, University Hospital Zurich
Zurich, Switzerland, 8091
Taiwan
National Cheng Kung University Hospital
Tainan City, Bei District, Taiwan, 704
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
Chang Gung Memorial Hospital Linkou Branch
Taichung, Taiwan, 40705
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Chi Mei Medical Center
Tainan City - Yongkang District, Taiwan, 710
Tri-Service General Hospital
Taipei city - Neihu District, Taiwan, 00114
Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
King Chulalongkorn Memorial Hospital
Patumwan, Bankok, Thailand, 10330
Maharaj Nakorn Chiang Mai Hospital
Amphoe Muang, Chiang Mai, Thailand, 50200
Songkhlanagarind Hospital
Hat Yai, Songkla, Thailand, 90110
United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
The Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Edinburgh Cancer Centre Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Beatson West of Scotland Cancer Centrel
Glasgow, United Kingdom, G12 0NY
Guy's and St Thomas' NHS, Westminister Bridge Road
London, United Kingdom, SE17EH
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Celldex Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT01480479     History of Changes
Other Study ID Numbers: CDX110-04
Study First Received: November 21, 2011
Last Updated: September 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Celldex Therapeutics:
EGFRvIII
Glioblastoma
Small cell
Giant cell
Gliosarcoma
oligodendroglial
Brain Cancer
Brain Tumor
radiotherapy
chemoradiation
Tumor
temozolomide
EGFR variant III

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014