Last updated on September 2007

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


Brief description of study

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.

Clinical Study Identifier: NCT00041626

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Recruitment Status: Open


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