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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.
 
ClinicalTrials.gov Identifier: NCT00412776
Recruitment Status : Terminated (Corporate reasons unrelated to safety and efficacy)
First Posted : December 18, 2006
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Viventia Bio

Tracking Information
First Submitted Date  ICMJE December 14, 2006
First Posted Date  ICMJE December 18, 2006
Last Update Posted Date December 23, 2015
Study Start Date  ICMJE December 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2007)
Survival [ Time Frame: Death or 12 months from the date that the last patient required for efficacy analysis has been randomized ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2006)
Survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2006)
Tumour response, safety and quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Squamous Cell of Head and Neck
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Head and Neck Cancer
Intervention  ICMJE Drug: Proxinium
700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression
Study Arms  ICMJE
  • Experimental: 1
    Proxinium plus Best Supportive Care
    Intervention: Drug: Proxinium
  • No Intervention: 2
    Best Supportive Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 7, 2008)
165
Original Enrollment  ICMJE
 (submitted: December 14, 2006)
292
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Argentina,   Brazil,   Croatia,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Ukraine,   United Kingdom
Removed Location Countries Former Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00412776
Other Study ID Numbers  ICMJE VB4-845-01-IIIA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Viventia Bio
Study Sponsor  ICMJE Viventia Bio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wendy Cuthbert Viventia Biotech Inc.
PRS Account Viventia Bio
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP