Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck

Inclusion Criteria: * Male and female patients ≥ 18 years of age. * Patients with documented histologic evidence of head and neck cancer with clinically measurable disease. Head and neck cancer could have been recurrent after primary treatment with surgery, radiation therapy and/or chemotherapy. * Measurable tumor by direct inspection, photography, or by imaging (CT scan or MRI). * Life expectancy of at least 3 months in the Investigators' opinion. * Negative pregnancy test if in women of childbearing potential within 1 week of starting therapy. * Patients had provided written informed consent to participate in study. * ECOG Performance Status of 0, 1, or 2. * Absolute neutrophil ≥ 1500/uL, hemoglobin ≥ 8 gm%, platelets ≥ 50,000/uL, * ALT/AST ≤ 3 x ULN (upper limit of the normal range), bilirubin ≤ 1.5 x ULN and creatinine ≤ 1.5 x ULN, PT and PTT within normal limits. Exclusion Criteria: * Women who were pregnant or nursing. * Women of child bearing potential who were unwilling to use an adequate method of contraception during the course of the study. * Treatment with prior investigational agent within 30 days of entering the study. * Patients who are unable to comply with the study requirements. * Patients with known sensitivity to any of the study medication components. * Patients not consenting to photography. * Patients with tumors that have enveloped the carotid artery or whose anatomy had been distorted such that in the Investigator's opinion present high-risk of perforation or compromise during injection. * Prior chemotherapy, radiation therapy, or surgery for the primary carcinoma within 30 days of dosing and/or had not recovered from prior therapy toxicities.