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

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.