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Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer
This study has been terminated.
Sponsored by: Viventia Biotech
Information provided by: Viventia Biotech
ClinicalTrials.gov Identifier: NCT00412776
  Purpose

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.


Condition Intervention Phase
Advanced Squamous Cell Carcinoma of the Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Mouth Neoplasms
Head and Neck Cancer
Drug: Proxinium
Phase II
Phase III

MedlinePlus related topics: Cancer Head and Neck Cancer Oral Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Squamous Cell Carcinoma of the Head and Neck Who Have Received at Least One Anti-Cancer Treatment Regimen for Advanced Disease

Further study details as provided by Viventia Biotech:

Primary Outcome Measures:
  • Survival [ Time Frame: Death or 12 months from the date that the last patient required for efficacy analysis has been randomized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumour response, safety and quality of life [ Time Frame: Death or 12 months from the date that the last patient required for efficacy analysis has been randomized ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: December 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Proxinium plus Best Supportive Care
Drug: Proxinium
700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression
2: No Intervention
Best Supportive Care

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412776

  Show 124 Study Locations
Sponsors and Collaborators
Viventia Biotech
Investigators
Study Director: Wendy Cuthbert Viventia Biotech Inc.
  More Information

Responsible Party: Viventia Biotech Inc ( Wendy Cuthbert )
Study ID Numbers: VB4-845-01-IIIA
Study First Received: December 14, 2006
Last Updated: September 8, 2008
ClinicalTrials.gov Identifier: NCT00412776  
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Brazil: National Health Surveillance Agency;   Israel: Ministry of Health;   Mexico: Federal Commission for Sanitary Risks Protection;   Russia: Ministry of Health and Social Development of the Russian Federation;   Ukraine: State Pharmacological Center - Ministry of Health;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Spain: Spanish Agency of Medicines;   France: Afssaps - French Health Products Safety Agency;   Poland: Ministry of Health;   Germany: Paul-Ehrlich-Institut;   India: Ministry of Health;   Italy: Ministry of Health;   Hungary: National Institute of Pharmacy;   Romania: National Medicines Agency;   Croatia: Ministry of Health and Social Care;   Serbia and Montenegro: Agency for Drugs and Medicinal Devices;   Slovakia: State Institute for Drug Control

Study placed in the following topic categories:
Mouth Diseases
Squamous cell carcinoma
Mouth Neoplasms
Carcinoma
Epidermoid carcinoma
Head and Neck Neoplasms
Oral cancer
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Stomatognathic Diseases
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009