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.