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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Wendy Cuthbert

Investigator Role:

Study Director

Investigator Affiliation:

Viventia Biotech Inc.

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

VB4-845-01-IIIA

NCT ID:

NCT00412776

Start Date:

December 2005

Completion Date:

April 2008

Related Keywords:

  • 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
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Neoplasms, Squamous Cell

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