Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer

This study has been terminated.

(Slow rates of accrual in North America, enrollment of more than 100 patients in a global study to confirm safe dose.)

Sponsor:

Information provided by:

Viventia Biotech

ClinicalTrials.gov Identifier:

NCT00272181

First received: January 3, 2006

Last updated: September 8, 2008

Last verified: September 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

January 3, 2006

Last Updated Date

September 8, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To determine the safety, tolerability and recommended dose (RD) of Proxinium [ Time Frame: Weekly dosing ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00272181 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer

Official Title ^ICMJE

A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Proxinium 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

Brief Summary

The purpose of this study is to determine the safety, effectiveness, and recommended dose of Proxinium in North American patients with Squamous Cell Head and Neck Cancer

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Recurrent Squamous Cell Carcinoma of the Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Mouth Neoplasms
Head and Neck Cancer

Intervention ^ICMJE

Drug: Proxinium

Intratumoral administration of Proxinium directly to target tumors.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Disease Characteristics:

Histologically confirmed recurrent squamous cell carcinoma of the head and neck.
Immunohistochemically confirmed epithelial cell adhesion molecule (EpCAM)-positive SCCHN.
Must have at least 1 accessible target tumor that is amenable to adequate direct injection.
The patient must have at least 1 accessible target tumor without direct carotid artery involvement.

Prior/Concurrent Therapy:

The patient must have received therapy for their primary disease
The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour.
The patient's disease must be refractory.
There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug.

Patient Characteristics:

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Life expectancy of at least 12 weeks.
Adequate hepatic function ALT and AST and total bilirubin levels ≤1.5 times ULN.
Adequate renal function (serum creatinine <2.0 mg/dL).
Hematologic values consisting of granulocytes ≥1500/μL, platelets ≥100 000/μL, and hemoglobin >8 g/dL.
Prothrombin time and partial thromboplastin time within normal limits

Other:

The patient must provide written informed consent.
Fertile patients must use effective contraception

Exclusion Criteria:

Brain tumor or brain metastases.
Nasopharyngeal SCCHN.
Human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen.
Uncontrolled bleeding from any target tumor(s) that are being considered for treatment or a history of tumor hemorrhage that has required medical intervention (other than direct compression).
The patient is a candidate for surgical tumor resection of their target tumor(s).
Pregnant or lactating.
Clinically significant renal or hepatic disease.
Requires regular use of aspirin, full-dose warfarin, or heparin.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00272181

Other Study ID Numbers ^ICMJE

VB4-845-01-IIA

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Viventia Biotech

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Wendy Cuthbert

Viventia Biotech

Information Provided By

Viventia Biotech

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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