Clinical Trial Details

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Study ID VB4-845-01-IIA
Investigator
Wendy Cuthbert,   Viventia Biotech
Title Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer
Conditions 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
Interventions Drug: Proxinium
Phase Phase 2
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
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
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.
  • Study Location
    CHUQ, L'Hotel-Dieu de Quebec
    Quebec City, Quebec, GIR 5C3
    Contact N/A

    Information objtained from ClinicalTrials.gov, on 10/31/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT00272181


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