Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced SCCHN Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease

The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell; Mouth Neoplasms; Carcinoma, Squamous Cell of Head and Neck
• Intervention / Treatment: Drug: Proxinium

Detailed Description

Head and neck cancer is a general description of a disease that includes several types of soft tissue carcinomas that develop in the head and neck regions.

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

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Bahia Blanca, Argentina
    • Hospital Italiano Regional del Sur
  • Bahia Blanca, Argentina
    • Hospital Municipal de Agudos Leonidas Lucero
  • Buenos Aires, Argentina
    • Hospital Universitario Austral
  • Buenos Aires, Argentina
    • Hospital de Clínicas "José de San Martín"
  • Buenos Aires, Argentina
    • Centro de Estudio y Tratamiento de las Enfermedades Neoplasicas (CETEN)
  • Buenos Aires, Argentina
    • Hospital Nacional Alejandro Posadas
  • La Plata, Argentina
    • Instituto Medico Platense
  • Rosario, Argentina
    • Hospital Italiano Garibaldi
• Brazil
  • Barretos, Brazil
    • Hospital de Cancer de Barretos - Fundacao Pio XII
  • Brasilia, Brazil
    • Cettro - Centro de Tratamento Oncológico Ltda.
  • Fortaleza, Brazil
    • Centro Regional Integrado de Oncologia - CRIO
  • Goiania - GO, Brazil
    • Hospital Araujo Jorge
  • Jau, Brazil
    • Hospital Amaral Carvalho
  • Londrina, Brazil
    • Pro-Onco Centro De Tratamento Oncológico S/C Ltda
  • Nova Lima, Brazil
    • Biocor - Hospital de Doenças Cardiovasculares Ltda
  • Piracicaba, Brazil
    • CECAN - Centro do Câncer Francisco Cunha Filho
  • Porto Alegre - RS, Brazil
    • Hospital Sao Lucas da PUCRS
  • Porto Alegre - RS, Brazil
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Riberao Preto-SP, Brazil
    • Instituto Ribeiraopretano de Combate Ao Cancer
  • Rio de Janeiro, Brazil
    • INCA - Instituto Nacional Do Cancer
  • Salvador - BA, Brazil
    • SOS Vida - Soluções em Saúde
  • Santo Andre-SP, Brazil
    • Santo André Diagnósticos e Tratamentos Ltda
  • São Paulo, Brazil
    • Hospital Do Câncer A. C. Camargo
  • São Paulo - SP, Brazil
    • Grupo de Pesquisas Médicas
  • São Paulo - SP, Brazil
    • Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
• Croatia
  • Zagreb, Croatia
    • 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
• France
  • Dijon, France
    • Centre Georges-Francois Leclerc
  • Le Havre, France
    • Clinique Guillaume Le Conquerant
  • Montpellier, France
    • Centre Regional de Lutte contre le Cancer Val d'Aurelle
• Germany
  • Berlin, Germany
    • Charité -Universitätsmedizin Berlin
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany
    • Universitat Heidelberg
  • Köln, Germany
    • Universitätsklinikum Köln
  • Leipzig, Germany
    • Universitatsklinikum Leipzig
  • Lübeck, Germany
    • Universitätsklinikum Schleswig Holstein
  • Mainz, Germany
    • Johannes Gutenberg-Universität
  • Marburg, Germany
    • Klinikum der Philipps-Universität Marburg
  • Tübingen, Germany
    • Universitätsklinikum Tübingen
• Hungary
  • Budapest, Hungary
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary
    • Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Fej-nyaksebeszet
  • Debrecen, Hungary
    • Debreceni Egyetem OEC, Onkologiai Tanszek
  • Gyor, Hungary
    • Petz Aladar Megyei Korhaz, Ful-orr-gege, Fej, Nyak Sebeszet
• India
  • Bangalore, India
    • Kidwai Memorial Institute of Oncology
  • Bangalore, India
    • Department of Medical Oncology, Bangalore Institute of Oncology
  • Hyderabaad, India
    • Nizam's Institute of Medical Sciences
  • Hyderabaad, India
    • Global Hospitals
  • Hyderabaad, India
    • MNJ Institute of Oncology
  • Jaipur, India
    • Birla Cancer Institute SMS Medical College Hospital
  • Jaipur, India
    • SK Soni Hospital
  • Karkhana, India
    • Soumya Hospita
  • Kochin, India
    • Amrita Institute of Medical Sciences and Research Centre
  • Kolkata, India
    • Orchid Nursing Home
  • Kolkata, India
    • Netaji Subash Chandra Bose Cancer Research Institute
  • Ludhiana, India
    • Department of Medical Oncology Dayanand Medical College & Hospital
  • Mumbai, India
    • Tata Memorial Hospital
  • Mumbai, India
    • Asian Institute of Oncology, S L Raheja Hospital
  • New Delhi, India
    • Department of Medical Oncology AIIMS, Institute Rotary Cancer Hospital
  • New Delhi, India
    • Department of Medical Oncology Rajiv Gandhi Cancer Institute and Research Centre
  • Trivandrum, India
    • Regional Cancer Centre
• Israel
  • Beer Sheva, Israel
    • Soroka university medical center
  • Haifa, Israel
    • The Lady Davis Carmel Medical Center
  • Jerusalem, Israel
    • Haddasa Ein Carem Hospital
  • Petach Tikva, Israel
    • Rabin Medical Center
  • Rehovot, Israel
    • Kaplan Medical Center
  • Tel Aviv, Israel
    • Tel Aviv University Medical School
  • Tel-Hashomer, Israel
    • Sheba - Medical Center
• Italy
  • Monza, Italy
    • Azienda Ospedaliera San Gerardo
  • Pavia, Italy
    • IRCCS Policlinico San Matteo
  • Pisa, Italy
    • Azienda Ospedaliera Pisana
• Mexico
  • Chihuahua, Chih., Mexico
    • Hospital Clínica del Parque
  • Merida, Mexico
    • Centro Anticanceroso de la Cruz Roja Mexicana de Mérida
  • Monterrey N.L., Mexico
    • OCA Hospital
  • San Luis Potosi, SLP, Mexico
    • Hospital Central "Dr. Ignacio Morones Prieto"
  • Zapopan, Jalisco, Mexico
    • Hospital "Dr. Angel Leaño"
• Poland
  • Kielce, Poland
    • Swietokrzyskie Centrum Onkologii
  • Krakow, Poland
    • Wojewodzki Szpital Specjalistyczny im. L.Rydygiera
  • Lodz, Poland
    • Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Regionalny Osrodek Onkologiczny
  • Olsztyn, Poland
    • Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii
  • Opole, Poland
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Opolskie Centrum Onkologii
  • Poznan, Poland
    • Wielkopolskie Centrum Onkologii
  • Warszawa, Poland
    • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
• Romania
  • Cluj-Napoca, Romania
    • "Prof. Dr. I. Chiricuta" Institute of Oncology Medical Oncology and Radiotherapy II Department
  • Oradea, Romania
    • Oradea Clinical County Hospital Department of Medical Oncology
• Russian Federation
  • Astrakhan, Russian Federation
    • Regional Oncology Dispensary
  • Ekaterinburg, Russian Federation
    • Sverdlovsk Regional Oncology Dispensary
  • Kursk, Russian Federation
    • State Medical Institution Kursk Regional Oncology Dispensary Out-patient department
  • Moscow, Russian Federation
    • Central Clinical Hospital #2 after MA Semashko OAO "RRW"
  • Moscow, Russian Federation
    • Moscow Scientific-Research Oncology Institute after P.A. Gertsen
  • Moscow, Russian Federation
    • SI Russian Oncology Scientific Center after NN Blokhin RAMS
  • Nizhniy Novgorod, Russian Federation
    • PHI OAO RRW Railway Clinical Hospital at station Gorkiy
  • Pyatigorsk, Russian Federation
    • Stavropol Regional Oncology Center, Pyatigorsk branch Out-patient department
  • Saratov, Russian Federation
    • PHI Dorozhnaya Clinical Hospital at Saratov II Station of Pryvolzhskaya railway OAO Russian Railways
  • St. Petersburg, Russian Federation
    • SIH Leningrad Regional Oncology Dispansery
  • St. Petersburg, Russian Federation
    • SPBSIH City Clinical Oncology Dispensary
  • Tambov, Russian Federation
    • Tambov Regional Oncological Dispensary Surgery Department
  • Ufa, Russian Federation
    • Republican Clinical Oncological Dispenser Radiological Therapy
  • Ulyanovsk, Russian Federation
    • State Medical Institution Regional Clinical Oncology Dispensary
• Serbia
  • Belgrade, Serbia
    • Institute for Oncology and Radiology of Serbia
  • Belgrade, Serbia
    • Military Medical Academy (MMA) Clinic for Maxillofacial Surgery
• Slovakia
  • Banská Bystrica, Slovakia
    • Teaching Hospital with Policlinic of F. D. Roosevelt Department of Otorhinolaryngology and Surgery
  • Bratislava, Slovakia
    • Oncology Institute of St. Elisabeth Clinic of Stomatology and Maxillofacial Surgery
  • Bratislava, Slovakia
    • Teaching Hospital with Policlinic Bratislava 1st Clinic of Otorhinolaryngology
  • Kosice, Slovakia
    • Vychodoslovensky oncologicky ustav a.s.
  • Nove Zamky, Slovakia
    • Teaching Hospital with Policlinic Nové Zámky Clinic of Otorhinolaryngology
• Spain
  • Barcelona, Spain
    • Hospital Vall d'Hebron
  • Barcelona, Spain
    • Hospital Santa Creu i Sant Pau
  • Madrid, Spain
    • Hospital Ramon y Cajal
  • Madrid, Spain
    • Hospital 12 de Octubre
  • Pontevedra, Spain
    • Hospital Provincial de Pontevedra
  • Salamanca, Castilla y León, Spain
    • Hospital Universitario de Salamanca
• Ukraine
  • Chernivtsy, Ukraine
    • Chernovtsy Regional Oncology Center
  • Kharkov, Ukraine
    • Kharkov Regional Clinical Oncology Dispensary
  • Kiev, Ukraine
    • Institute of Oncology of AMS of Ukraine
  • Kiev, Ukraine
    • Institute of Otolaryngology
  • Lutsk, Ukraine
    • Volyn Regional Oncology Dispensary
  • Uzhorod, Ukraine
    • Uzhgorod National University
  • Zaporozhye, Ukraine
    • Zaporozhye Regional Clinical Oncology Dispensary
• United Kingdom
  • Liverpool, United Kingdom
    • University Hospital Aintree
  • London, United Kingdom
    • Royal Marsden Hospital
  • Manchester, United Kingdom
    • Christie Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Disease Characteristics

• 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 has clinically significant distant metastases.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Proxinium plus Best Supportive Care	Drug: Proxinium; 700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression
No Intervention: 2; Best Supportive Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival	Death or 12 months from the date that the last patient required for efficacy analysis has been randomized

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumour response, safety and quality of life	Death or 12 months from the date that the last patient required for efficacy analysis has been randomized

Collaborators and Investigators

• Sponsor: Sesen Bio, Inc.
• Investigators: Study Director: Wendy Cuthbert, Viventia Biotech Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: December 14, 2006
• First Submitted That Met QC Criteria: December 14, 2006
• First Posted (Estimate): December 18, 2006

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Stomatognathic Diseases; Mouth Diseases; Neoplasms; Head and Neck Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplasms, Squamous Cell; Mouth Neoplasms
• Other Study ID Numbers: VB4-845-01-IIIA