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

This study has been terminated.
(Corporate reasons unrelated to safety and efficacy)
Sponsor:
Information provided by:
Viventia Biotech
ClinicalTrials.gov Identifier:
NCT00412776
First received: December 14, 2006
Last updated: September 8, 2008
Last verified: September 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Squamous Cell Carcinoma of the Head and Neck Who Have Received at Least One Anti-Cancer Treatment Regimen for Advanced Disease

Resource links provided by NLM:


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
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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412776

  Show 122 Study Locations
Sponsors and Collaborators
Viventia Biotech
Investigators
Study Director: Wendy Cuthbert Viventia Biotech Inc.
  More Information

No publications provided

Responsible Party: Wendy Cuthbert, Viventia Biotech Inc
ClinicalTrials.gov Identifier: NCT00412776     History of Changes
Other Study ID Numbers: VB4-845-01-IIIA
Study First Received: December 14, 2006
Last Updated: September 8, 2008
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 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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Mouth Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 31, 2014