A Phase II, open-label study to evaluate the safety, tolerability, and pharmacokinetic profile of Proxinium™ in patients with recurrent squamous cell carcinoma of the head and neck who have received at least one prior anti-cancer treatment regimen for recurrent disease

Phase 2

Completed

• Conditions: Squamous Cell Carcinoma of the Head and Neck; Cancer

• Registration Number: ISRCTN81721411
• Lead Sponsor: Viventia Biotech Inc (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-17
• Study Completion: 2006-11-30
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. The patient must have histologically confirmed SCCHN
2. The patient must have immunohistochemically confirmed Epithelial Cell Adhesion Molecule (Ep-CAM)?positive SCCHN
3. The patient must have received therapy for their primary disease (i.e., SCCHN) consisting of radiotherapy with or without surgery and with or without chemotherapy
4. Patients must have progressed on or after receiving at least one prior anti-cancer treatment regimen containing one or more anti-cancer agents (e.g., chemotherapy, biologic therapy, or photodynamic therapy) for their recurrent disease
5. The patient must have fully recovered or reached a stable state of symptomatology from any previous treatment-related toxicity
6. The patient must have at least one accessible target tumor without direct carotid artery involvement (ie, a distance of less than 5 mm between a tumor and carotid) and must be likely to retain study drug

Exclusion Criteria

1. The patient has known brain tumor or brain metastases
2. The patient has nasopharyngeal SCCHN
3. The patient has concurrent or documented history of any one of the following:
a. Human Immunodeficiency Virus (HIV)
b. Hepatitis C virus
c. Hepatitis B surface antigen
4. The patient has uncontrolled bleeding from any target tumor(s) that are being considered for Proxinium™ treatment
5. The patient has a history of tumor hemorrhage that has required medical intervention (other than direct compression)
6. The patient is a candidate for surgical tumor resection of their target tumor(s)
7. The patient is pregnant or lactating
8.The patient has clinically significant renal or hepatic disease
9. The patient requires regular use of aspirin, full-dose warfarin, or heparin. Use of low-dose agents to maintain patency of vascular catheters is allowed

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine safety, tolerability and pharmacokinetic profile of Proxinium™ in SCCHN patients.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Tumour response rates<br> 2. Time to progression<br> 3. Overall Survival<br> 4. Progression free survival associated with intratumoral injection of Proxinium™<br>