Condition category
Cancer
Date applied
06/04/2006
Date assigned
17/08/2006
Last edited
08/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jerald Kahan

ORCID ID

Contact details

4009 Banister Lane
Austin
78704
United States of America
+1 512 685 5779
jerald.kahan@austin.ppdi.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00272181

Protocol/serial number

VB4-845-01-IIA

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the safety, tolerability and pharmacokinetic profile of Proxinium™ in patients with recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Ethics approval

Approved by Institutional Review Boards at various Universities, Hospitals and Clinics in North America, also approved by the Food and Drug Administration on 17/11/2005 (reference number: 12610).

Study design

Multicenter open-label safety study

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Squamous Cell Carcinoma of the Head and Neck

Intervention

Proxinium™ injected intratumorally weekly.

Intervention type

Drug

Phase

Phase II

Drug names

Proxinium¿

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

16/12/2005

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

18

Participant 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

Recruitment start date

16/12/2005

Recruitment end date

30/11/2006

Locations

Countries of recruitment

Canada, United States of America

Trial participating centre

4009 Banister Lane
Austin
78704
United States of America

Sponsor information

Organisation

Viventia Biotech Inc (Canada)

Sponsor details

5060 Spectrum Way
Suite 405
Mississauga
L4W 5N5
Canada

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Viventia Biotech Inc (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes