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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00412776
Recruitment Status : Terminated (Corporate reasons unrelated to safety and efficacy)
First Posted : December 18, 2006
Last Update Posted : December 23, 2015
Information provided by (Responsible Party):
Viventia Bio

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell of Head and Neck Carcinoma, Squamous Cell Neoplasms, Squamous Cell Head and Neck Neoplasms Mouth Neoplasms Head and Neck Cancer Drug: Proxinium Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Survival [ Time Frame: Death or 12 months from the date that the last patient required for efficacy analysis has been randomized ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


• 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00412776

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Sponsors and Collaborators
Viventia Bio
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Study Director: Wendy Cuthbert Viventia Biotech Inc.
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Responsible Party: Viventia Bio Identifier: NCT00412776    
Other Study ID Numbers: VB4-845-01-IIIA
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mouth Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Mouth Diseases
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Stomatognathic Diseases