Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate

There is a need for more treatment options for patients with recurrent squamous cell cancer
of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that
include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the
development of tumors. In this study the transfer of the p53 gene to tumor cells using a
modified adenovirus (INGN 201) will be compared to methotrexate in patients who have failed
surgery, radiotherapy and chemotherapy with platinum or taxanes.