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

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.