Clinical trial NCT00412776: Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Carcinoma, Squamous Cell of Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Mouth Neoplasms
Head and Neck Cancer
Lead sponsor: Sesen Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2006-12-18
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

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