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
| ISRCTN | ISRCTN81721411 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81721411 |
| ClinicalTrials.gov number | NCT00272181 |
| Secondary identifying numbers | VB4-845-01-IIA |
- Submission date
- 06/04/2006
- Registration date
- 17/08/2006
- Last edited
- 28/01/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jerald Kahan
Scientific
Scientific
4009 Banister Lane
Austin
78704
United States of America
| Phone | +1 512 685 5779 |
|---|---|
| jerald.kahan@austin.ppdi.com |
Study information
| Study design | Multicenter open-label safety study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | Squamous Cell Carcinoma of the Head and Neck |
| Intervention | Proxinium™ injected intratumorally weekly. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 16/12/2005 |
| Completion date | 30/11/2006 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 18 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/12/2005 |
| Date of final enrolment | 30/11/2006 |
Locations
Countries of recruitment
- Canada
- United States of America
Study participating centre
4009 Banister Lane
Austin
78704
United States of America
78704
United States of America
Sponsor information
Viventia Biotech Inc (Canada)
Industry
Industry
5060 Spectrum Way
Suite 405
Mississauga
L4W 5N5
Canada
"ROR" |
https://ror.org/0440s3562 |
|---|
Funders
Funder type
Industry
Viventia Biotech Inc (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
28/01/2019: Clinicaltrials.gov stated that this trial was terminated by October 2007 due to slow accrual
