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

Phase 2

Terminated

• Conditions: Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Carcinoma, Squamous Cell of Head and Neck; Head and Neck Neoplasms; Head and Neck Cancer; Mouth Neoplasms
• Interventions: Drug: Proxinium

• Registration Number: NCT00412776
• Lead Sponsor: Sesen Bio, Inc.

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

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-12-14
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-18
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Proxinium	Proxinium plus Best Supportive Care

Primary Outcome Measures

Name	Time	Method
Survival	Death or 12 months from the date that the last patient required for efficacy analysis has been randomized

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (122)

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

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

Centro Regional Integrado de Oncologia - CRIO; 🇧🇷 Fortaleza, Brazil

Irmandade Santa Casa de Misericórdia de Porto Alegre; 🇧🇷 Porto Alegre - RS, Brazil

CECAN - Centro do Câncer Francisco Cunha Filho; 🇧🇷 Piracicaba, Brazil

Biocor - Hospital de Doenças Cardiovasculares Ltda; 🇧🇷 Nova Lima, Brazil

SOS Vida - Soluções em Saúde; 🇧🇷 Salvador - BA, Brazil

Instituto Ribeirãopretano de Combate ao Câncer; 🇧🇷 Riberao Preto-SP, Brazil

INCA - Instituto Nacional do Câncer; 🇧🇷 Rio de Janeiro, Brazil

Santo André Diagnósticos e Tratamentos Ltda; 🇧🇷 Santo Andre-SP, Brazil

Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo - SP, Brazil

Hospital Do Câncer A. C. Camargo; 🇧🇷 São Paulo, Brazil

Clinical Hospital "Sestre milosrdnice"; 🇭🇷 Zagreb, Croatia

Clinical Hospital Centre Zagreb, Clinic for ENT, Department for Head and Neck Surgery; 🇭🇷 Zagreb, Croatia

Centre Georges-Francois Leclerc; 🇫🇷 Dijon, France

Universtity Hospital for Tumors, Department for Head and Neck Surgery; 🇭🇷 Zagreb, Croatia

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; 🇩🇪 Köln, Germany

Johannes Gutenberg-Universität; 🇩🇪 Mainz, Germany

Klinikum der Philipps-Universität Marburg; 🇩🇪 Marburg, Germany

Orszagos Onkologiai Intezet; 🇭🇺 Budapest, Hungary

Petz Aladar Megyei Korhaz, Ful-orr-gege, Fej, Nyak Sebeszet; 🇭🇺 Gyor, Hungary

Debreceni Egyetem OEC, Onkologiai Tanszek; 🇭🇺 Debrecen, Hungary

SK Soni Hospital; 🇮🇳 Jaipur, India

MNJ Institute of Oncology; 🇮🇳 Hyderabaad, India

Netaji Subash Chandra Bose Cancer Research Institute; 🇮🇳 Kolkata, India

Birla Cancer Institute SMS Medical College Hospital; 🇮🇳 Jaipur, India

Nizam's Institute of Medical Sciences; 🇮🇳 Hyderabaad, India

Soumya Hospita; 🇮🇳 Karkhana, India

Department of Medical Oncology Dayanand Medical College & Hospital; 🇮🇳 Ludhiana, India

Tata Memorial Hospital; 🇮🇳 Mumbai, India

Asian Institute of Oncology, S L Raheja 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

The Lady Davis Carmel Medical Center; 🇮🇱 Haifa, Israel

Haddasa Ein Carem Hospital; 🇮🇱 Jerusalem, Israel

Tel Aviv University Medical School; 🇮🇱 Tel Aviv, Israel

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

Sheba - Medical Center; 🇮🇱 Tel-Hashomer, Israel

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel

Azienda Ospedaliera San Gerardo; 🇮🇹 Monza, Italy

Hospital Clínica del Parque; 🇲🇽 Chihuahua, Chih., Mexico

OCA Hospital; 🇲🇽 Monterrey N.L., Mexico

Centro Anticanceroso de la Cruz Roja Mexicana de Mérida; 🇲🇽 Merida, Mexico

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

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie; 🇵🇱 Warszawa, Poland

Wielkopolskie Centrum Onkologii; 🇵🇱 Poznan, Poland

Sverdlovsk Regional Oncology Dispensary; 🇷🇺 Ekaterinburg, Russian Federation

Oradea Clinical County Hospital Department of Medical Oncology; 🇷🇴 Oradea, Romania

Regional Oncology Dispensary; 🇷🇺 Astrakhan, Russian Federation

State Medical Institution Kursk Regional Oncology Dispensary Out-patient department; 🇷🇺 Kursk, Russian Federation

Central Clinical Hospital #2 after MA Semashko OAO "RRW"; 🇷🇺 Moscow, Russian Federation

SI Russian Oncology Scientific Center after NN Blokhin RAMS; 🇷🇺 Moscow, Russian Federation

PHI OAO RRW Railway Clinical Hospital at station Gorkiy; 🇷🇺 Nizhniy Novgorod, Russian Federation

PHI Dorozhnaya Clinical Hospital at Saratov II Station of Pryvolzhskaya railway OAO Russian Railways; 🇷🇺 Saratov, Russian Federation

SPBSIH City Clinical Oncology Dispensary; 🇷🇺 St. Petersburg, Russian Federation

Tambov Regional Oncological Dispensary Surgery Department; 🇷🇺 Tambov, Russian Federation

State Medical Institution Regional Clinical Oncology Dispensary; 🇷🇺 Ulyanovsk, Russian Federation

Institute for Oncology and Radiology of Serbia; 🇷🇸 Belgrade, Serbia

Republican Clinical Oncological Dispenser Radiological Therapy; 🇷🇺 Ufa, Russian Federation

Oncology Institute of St. Elisabeth Clinic of Stomatology and Maxillofacial Surgery; 🇸🇰 Bratislava, Slovakia

Military Medical Academy (MMA) Clinic for Maxillofacial Surgery; 🇷🇸 Belgrade, Serbia

Teaching Hospital with Policlinic Nové Zámky Clinic of Otorhinolaryngology; 🇸🇰 Nove Zamky, Slovakia

Hospital Provincial de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Castilla y León, Spain

Institute of Otolaryngology; 🇺🇦 Kiev, Ukraine

Chernovtsy Regional Oncology Center; 🇺🇦 Chernivtsy, Ukraine

Uzhgorod National University; 🇺🇦 Uzhorod, Ukraine

Zaporozhye Regional Clinical Oncology Dispensary; 🇺🇦 Zaporozhye, Ukraine

University Hospital Aintree; 🇬🇧 Liverpool, United Kingdom

Royal Marsden Hospital; 🇬🇧 London, United Kingdom

Christie Hospital; 🇬🇧 Manchester, United Kingdom

Grupo de Pesquisas Médicas; 🇧🇷 São Paulo - SP, Brazil

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Global Hospitals; 🇮🇳 Hyderabaad, India

Amrita Institute of Medical Sciences and Research Centre; 🇮🇳 Kochin, India

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Teaching Hospital with Policlinic Bratislava 1st Clinic of Otorhinolaryngology; 🇸🇰 Bratislava, Slovakia

Institute of Oncology of AMS of Ukraine; 🇺🇦 Kiev, Ukraine

Volyn Regional Oncology Dispensary; 🇺🇦 Lutsk, Ukraine

Moscow Scientific-Research Oncology Institute after P.A. Gertsen; 🇷🇺 Moscow, Russian Federation

Vychodoslovensky oncologicky ustav a.s.; 🇸🇰 Kosice, Slovakia

Hospital "Dr. Angel Leaño"; 🇲🇽 Zapopan, Jalisco, Mexico

"Prof. Dr. I. Chiricuta" Institute of Oncology Medical Oncology and Radiotherapy II Department; 🇷🇴 Cluj-Napoca, Romania

SIH Leningrad Regional Oncology Dispansery; 🇷🇺 St. Petersburg, Russian Federation

Hospital Italiano Regional del Sur; 🇦🇷 Bahia Blanca, Argentina

Hospital Amaral Carvalho; 🇧🇷 Jau, Brazil

Department of Medical Oncology, Bangalore Institute of Oncology; 🇮🇳 Bangalore, India

Orchid Nursing Home; 🇮🇳 Kolkata, India

Hospital Municipal de Agudos Leonidas Lucero; 🇦🇷 Bahia Blanca, Argentina

Hospital São Lucas da PUCRS; 🇧🇷 Porto Alegre - RS, Brazil

Regional Cancer Centre; 🇮🇳 Trivandrum, India

Hospital Central "Dr. Ignacio Morones Prieto"; 🇲🇽 San Luis Potosi, SLP, Mexico

Swietokrzyskie Centrum Onkologii; 🇵🇱 Kielce, Poland

Kharkov Regional Clinical Oncology Dispensary; 🇺🇦 Kharkov, Ukraine

Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Fej-nyaksebeszet; 🇭🇺 Budapest, Hungary

Cettro - Centro de Tratamento Oncológico Ltda.; 🇧🇷 Brasilia, Brazil

Hospital Araújo Jorge; 🇧🇷 Goiania - GO, Brazil

Pro-Onco Centro De Tratamento Oncológico S/C Ltda; 🇧🇷 Londrina, Brazil

Universität Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Schleswig Holstein; 🇩🇪 Lübeck, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Kidwai Memorial Institute of Oncology; 🇮🇳 Bangalore, India

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel

Azienda Ospedaliera Pisana; 🇮🇹 Pisa, Italy

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Opolskie Centrum Onkologii; 🇵🇱 Opole, Poland

Stavropol Regional Oncology Center, Pyatigorsk branch Out-patient department; 🇷🇺 Pyatigorsk, Russian Federation

Teaching Hospital with Policlinic of F. D. Roosevelt Department of Otorhinolaryngology and Surgery; 🇸🇰 Banská Bystrica, Slovakia