Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone

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) in combination with chemotherapy (cisplatin and fluorouracil)
will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed
surgery and radiotherapy.