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
  Purpose

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


Condition Intervention Phase
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
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Viventia Biotech:

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

Enrollment: 15
Study Start Date: January 2006
Study Completion Date: October 2007
Intervention Details:
    Drug: Proxinium
    Intratumoral administration of Proxinium directly to target tumors.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272181

  Show 19 Study Locations
Sponsors and Collaborators
Viventia Biotech
Investigators
Study Director: Wendy Cuthbert Viventia Biotech
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00272181     History of Changes
Obsolete Identifiers: NCT00335842
Other Study ID Numbers: VB4-845-01-IIA
Study First Received: January 3, 2006
Last Updated: September 8, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Mouth Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 24, 2014