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

• Conditions: Advanced Ep-CAM Positive Squamous Cell Carcinoma of the Head and Neck

• Registration Number: EUCTR2005-005170-80-DE
• Lead Sponsor: Viventia Biotech Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

1. The patient must be 18 years of age or older.
2. The patient must be able to comply with scheduled study assessments and in-person visits and must have an ECOG performance status of 0, 1, 2 or 3.
3. The patient must have a life expectancy of at least 12 weeks.
4. The patient must have histologically-confirmed SCCHN.
5. The patient must have immunohistochemically-confirmed Ep-CAM-positive SCCHN.
6. The patient must have received curative intent therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy).
7. The patient must have documented advanced disease following treatment for their primary disease (ie, persistent or recurrent disease or second primary tumour).
8. The patient’s advanced disease must be refractory, meaning that the patient must have progressed on or after receiving, or was unable to tolerate, at least 1 anti-cancer treatment regimen containing 1 or more anti-cancer agents for their advanced disease, or the patient must have documented refusal of chemotherapy treatment for advanced disease.
9. The patient must meet the requirement of a minimum period of 2 weeks between the last dose of radiotherapy or chemotherapy or 4 weeks between the last dose of an investigational anti-cancer product, and the first dose of the study drug.
10. The patient must have fully recovered or reached a stable state of symptomatology from any previous treatment-related toxicity.
11. The patient must have at least 1 target tumour that can be designated a principal target tumour.
12. 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].
13. The patient must have adequate renal function (serum creatinine < 1.5 × ULN).
14. The patient must have the following hematological values: granulocytes =1500/µL, platelets =75 000/µL and hemoglobin >8 g/dL.
15. The patient must have prothrombin time and partial thromboplastin time within normal limits.
16. The patient must provide written informed consent.
17. Women of childbearing potential (WOCBP) and male patients must be surgically incapable of bearing children or must agree to use a highly effective contraceptive method.
Note: The ICH guidelines define a highly effective contraceptive method as one with a failure rate of less than 1% when used consistently and correctly, such as the double barrier method.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The patient’s locoregional disease is predominantly composed of tumours that do not meet the criteria of a target tumour.
2. The patient has clinically significant distant metastases, including brain metastases.
3. The patient is a candidate for either curative surgical resection or curative intent radiotherapy, chemo-radiotherapy or chemotherapy for their advanced disease.
4. The patient has nasopharyngeal SCCHN.
5. The patient has concurrent or documented history of any 1 of the following: known Acquired Immunodeficiency Syndrome, hepatitis C or hepatitis B.
6. The patient has clinically significant renal or hepatic disease.
7. The patient has Grade 3, or higher, bleeding from any tumour.
8. The patient is pregnant or lactating.
9. The patient requires regular use of therapy that significantly alters coagulation parameters to values that exceed the ULN and are unable to safely discontinue that therapy prior to randomization.
10. The patient has any concomitant condition that, in the Investigator’s opinion, would make the patient inappropriate for study.
11. The patient is currently enrolled in a clinical trial for another investigational therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To compare the overall survival time associated with intratumourally injected Proxinium plus BSC versus BSC in patients with advanced SCCHN who have received at least 1 anti-cancer treatment regimen for advanced disease.;Secondary Objective: 1. To compare locoregional tumour control, as assessed by the locoregional response rate and duration of locoregional response, for patients treated with Proxinium plus BSC versus BSC.<br>2. To compare the local progression-free survival for patients treated with Proxinium plus BSC versus BSC.<br>3. To compare the symptomatic benefit for patients treated with Proxinium plus BSC versus BSC.<br>4. To compare the safety profile for patients treated with Proxinium plus BSC versus BSC.<br>;Primary end point(s): Overall survival time, measured as the time from randomization to death from any cause.