Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer
NCT ID: NCT00412776
Last Updated: 2015-12-23
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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TERMINATED
PHASE2/PHASE3
165 participants
INTERVENTIONAL
2005-12-31
2008-04-30
Brief Summary
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Detailed Description
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Proxinium is a recombinant fusion protein that binds to the epithelial cell adhesion molecule (Ep-CAM) that is highly expressed on squamous cell carcinomas of the head and neck (SCCHN). Proxinium is administered via intratumoural injection.
The primary objective of the study is to compare the overall survival time for patients treated with intratumourally injected Proxinium plus BSC versus BSC alone. Secondary objectives of the study include comparison of locoregional tumour control, local progression-free survival, symptomatic benefit and safety profile in patients who receive Proxinium plus BSC versus patients who receive BSC
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Proxinium plus Best Supportive Care
Proxinium
700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression
2
Best Supportive Care
No interventions assigned to this group
Interventions
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Proxinium
700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression
Eligibility Criteria
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Inclusion Criteria
* The patient must be 18 years of age or older.
* The patient must have squamous cell carcinoma of the head and neck.
* The squamous cell carcinoma must be Ep-CAM positive.
* ECOG performance status of 0, 1, 2 or 3.
* 12 week life expectancy
Prior/Concurrent Therapy
* The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy).
* The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour.
* The patient's disease must be refractory.
* There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug.
Patient Characteristics
* The patient must have adequate hepatic function \[alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN\].
* The patient must have adequate renal function (serum creatinine \< 1.5 × ULN).
* The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin \>8 g/dL.
* The patient must have prothrombin time and partial thromboplastin time within normal limits.
Other
• Women of childbearing potential and male patients must agree to use a highly effective contraceptive method.
Exclusion Criteria
* The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy.
* The patient has a nasopharyngeal tumour.
* The patient has AIDS, hepatitis C or hepatitis B.
* The patient has clinically significant renal or hepatic disease.
* Tumors are prone to bleeding.
* The patient is pregnant or lactating.
* The patient requires 'blood thinning' medications and can not safely discontinue the medication.
* The patient is currently enrolled in another clinical trial.
18 Years
ALL
No
Sponsors
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Sesen Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Wendy Cuthbert
Role: STUDY_DIRECTOR
Viventia Biotech Inc.
Locations
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Hospital Italiano Regional del Sur
Bahía Blanca, , Argentina
Hospital Municipal de Agudos Leonidas Lucero
Bahía Blanca, , Argentina
Centro de Estudio y Tratamiento de las Enfermedades Neoplasicas (CETEN)
Buenos Aires, , Argentina
Hospital de Clinicas "Jose de San Martin"
Buenos Aires, , Argentina
Hospital Nacional Alejandro Posadas
Buenos Aires, , Argentina
Hospital Universitario Austral
Buenos Aires, , Argentina
Instituto Medico Platense
La Plata, , Argentina
Hospital Italiano Garibaldi
Rosario, , Argentina
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos, , Brazil
Cettro - Centro de Tratamento Oncológico Ltda.
Brasília, , Brazil
Centro Regional Integrado de Oncologia - CRIO
Fortaleza, , Brazil
Hospital Araújo Jorge
Goiania - GO, , Brazil
Hospital Amaral Carvalho
Jaú, , Brazil
Pro-Onco Centro De Tratamento Oncológico S/C Ltda
Londrina, , Brazil
Biocor - Hospital de Doenças Cardiovasculares Ltda
Nova Lima, , Brazil
CECAN - Centro do Câncer Francisco Cunha Filho
Piracicaba, , Brazil
Hospital São Lucas da PUCRS
Porto Alegre - RS, , Brazil
Irmandade Santa Casa de Misericórdia de Porto Alegre
Porto Alegre - RS, , Brazil
Instituto Ribeirãopretano de Combate ao Câncer
Riberao Preto-SP, , Brazil
INCA - Instituto Nacional do Câncer
Rio de Janeiro, , Brazil
SOS Vida - Soluções em Saúde
Salvador - BA, , Brazil
Santo André Diagnósticos e Tratamentos Ltda
Santo Andre-SP, , Brazil
Hospital Do Câncer A. C. Camargo
São Paulo, , Brazil
Grupo de Pesquisas Médicas
São Paulo - SP, , Brazil
Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo
São Paulo - SP, , Brazil
Clinical Hospital "Sestre milosrdnice"
Zagreb, , Croatia
Clinical Hospital Centre Zagreb, Clinic for ENT, Department for Head and Neck Surgery
Zagreb, , Croatia
Universtity Hospital for Tumors, Department for Head and Neck Surgery
Zagreb, , Croatia
Centre Georges-Francois Leclerc
Dijon, , France
Clinique Guillaume Le Conquerant
Le Havre, , France
Centre Régional de Lutte contre le Cancer Val d'Aurelle
Montpellier, , France
Charité -Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universität Heidelberg
Heidelberg, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universitätsklinikum Schleswig Holstein
Lübeck, , Germany
Johannes Gutenberg-Universität
Mainz, , Germany
Klinikum der Philipps-Universität Marburg
Marburg, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Fej-nyaksebeszet
Budapest, , Hungary
Orszagos Onkologiai Intezet
Budapest, , Hungary
Debreceni Egyetem OEC, Onkologiai Tanszek
Debrecen, , Hungary
Petz Aladar Megyei Korhaz, Ful-orr-gege, Fej, Nyak Sebeszet
Győr, , Hungary
Department of Medical Oncology, Bangalore Institute of Oncology
Bangalore, , India
Kidwai Memorial Institute of Oncology
Bangalore, , India
Global Hospitals
Hyderabaad, , India
MNJ Institute of Oncology
Hyderabaad, , India
Nizam's Institute of Medical Sciences
Hyderabaad, , India
Birla Cancer Institute SMS Medical College Hospital
Jaipur, , India
SK Soni Hospital
Jaipur, , India
Soumya Hospita
Karkhāna, , India
Amrita Institute of Medical Sciences and Research Centre
Kochi, , India
Netaji Subash Chandra Bose Cancer Research Institute
Kolkata, , India
Orchid Nursing Home
Kolkata, , India
Department of Medical Oncology Dayanand Medical College & Hospital
Ludhiana, , India
Asian Institute of Oncology, S L Raheja Hospital
Mumbai, , India
Tata Memorial Hospital
Mumbai, , India
Department of Medical Oncology AIIMS, Institute Rotary Cancer Hospital
New Delhi, , India
Department of Medical Oncology Rajiv Gandhi Cancer Institute and Research Centre
New Delhi, , India
Regional Cancer Centre
Trivandrum, , India
Soroka University Medical Center
Beersheba, , Israel
The Lady Davis Carmel Medical Center
Haifa, , Israel
Haddasa Ein Carem Hospital
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv University Medical School
Tel Aviv, , Israel
Sheba - Medical Center
Tel Litwinsky, , Israel
Azienda Ospedaliera San Gerardo
Monza, , Italy
IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera Pisana
Pisa, , Italy
Hospital Clínica del Parque
Chihuahua, Chih., , Mexico
Centro Anticanceroso de la Cruz Roja Mexicana de Mérida
Mérida, , Mexico
OCA Hospital
Monterrey N.L., , Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi, SLP, , Mexico
Hospital "Dr. Angel Leaño"
Zapopan, Jalisco, , Mexico
Swietokrzyskie Centrum Onkologii
Kielce, , Poland
Wojewodzki Szpital Specjalistyczny im. L.Rydygiera
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Regionalny Osrodek Onkologiczny
Lodz, , Poland
Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii
Olsztyn, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Opolskie Centrum Onkologii
Opole, , Poland
Wielkopolskie Centrum Onkologii
Poznan, , Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Warsaw, , Poland
"Prof. Dr. I. Chiricuta" Institute of Oncology Medical Oncology and Radiotherapy II Department
Cluj-Napoca, , Romania
Oradea Clinical County Hospital Department of Medical Oncology
Oradea, , Romania
Regional Oncology Dispensary
Astrakhan, , Russia
State Medical Institution Kursk Regional Oncology Dispensary Out-patient department
Kursk, , Russia
Central Clinical Hospital #2 after MA Semashko OAO "RRW"
Moscow, , Russia
Moscow Scientific-Research Oncology Institute after P.A. Gertsen
Moscow, , Russia
SI Russian Oncology Scientific Center after NN Blokhin RAMS
Moscow, , Russia
PHI OAO RRW Railway Clinical Hospital at station Gorkiy
Nizhny Novgorod, , Russia
Stavropol Regional Oncology Center, Pyatigorsk branch Out-patient department
Pyatigorsk, , Russia
SIH Leningrad Regional Oncology Dispansery
Saint Petersburg, , Russia
SPBSIH City Clinical Oncology Dispensary
Saint Petersburg, , Russia
PHI Dorozhnaya Clinical Hospital at Saratov II Station of Pryvolzhskaya railway OAO Russian Railways
Saratov, , Russia
Tambov Regional Oncological Dispensary Surgery Department
Tambov, , Russia
Republican Clinical Oncological Dispenser Radiological Therapy
Ufa, , Russia
State Medical Institution Regional Clinical Oncology Dispensary
Ulyanovsk, , Russia
Sverdlovsk Regional Oncology Dispensary
Yekaterinburg, , Russia
Institute for Oncology and Radiology of Serbia
Belgrade, , Serbia
Military Medical Academy (MMA) Clinic for Maxillofacial Surgery
Belgrade, , Serbia
Teaching Hospital with Policlinic of F. D. Roosevelt Department of Otorhinolaryngology and Surgery
Banská Bystrica, , Slovakia
Oncology Institute of St. Elisabeth Clinic of Stomatology and Maxillofacial Surgery
Bratislava, , Slovakia
Teaching Hospital with Policlinic Bratislava 1st Clinic of Otorhinolaryngology
Bratislava, , Slovakia
Vychodoslovensky oncologicky ustav a.s.
Košice, , Slovakia
Teaching Hospital with Policlinic Nové Zámky Clinic of Otorhinolaryngology
Nové Zámky, , Slovakia
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Provincial de Pontevedra
Pontevedra, , Spain
Hospital Universitario de Salamanca
Salamanca, Castilla Y León, , Spain
Chernovtsy Regional Oncology Center
Chernivtsy, , Ukraine
Kharkov Regional Clinical Oncology Dispensary
Kharkiv, , Ukraine
Institute of Oncology of AMS of Ukraine
Kiev, , Ukraine
Institute of Otolaryngology
Kiev, , Ukraine
Volyn Regional Oncology Dispensary
Lutsk, , Ukraine
Uzhgorod National University
Uzhhorod, , Ukraine
Zaporozhye Regional Clinical Oncology Dispensary
Zaporizhzhya, , Ukraine
University Hospital Aintree
Liverpool, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Countries
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Other Identifiers
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VB4-845-01-IIIA
Identifier Type: -
Identifier Source: org_study_id