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

January 3, 2006
September 8, 2008
January 2006
Not Provided
To determine the safety, tolerability and recommended dose (RD) of Proxinium [ Time Frame: Weekly dosing ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00272181 on ClinicalTrials.gov Archive Site
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Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer
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

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Drug: Proxinium
Intratumoral administration of Proxinium directly to target tumors.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
October 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
NCT00272181
VB4-845-01-IIA
No
Not Provided
Viventia Biotech
Not Provided
Study Director: Wendy Cuthbert Viventia Biotech
Viventia Biotech
September 2008

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