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.