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
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
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 measure
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 (if study stopped)
Participant recruitment issue
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
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
Basic results (scientific)
Publication list