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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James Suen, MD

University of Arkansas
Little Rock, AR United States
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Madeleine Kane, MD

Unversity of Colorado Cancer Center
Aurora, CO United States
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Jarrad Goodwin, MD

University of Miami Hospital and Sylvester Comprehensive Cancer Center
Miami, FL United States
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John Hamm, MD

Norton Healthcare Pavilion
Louisville, KY United States
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Marshall Levine, MD

Center Center of GBMC
Baltimore, MD United States
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William Hrushesky, MD

WJB Dorn VA Medical Center
Columbia, SC United States
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John Nemunaitis, MD

Mary Crowley Medical Research Center
Dallas, TX United States
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Gary Clayman, MD

University of Texas, MD Andersen Cancer Center
Houston, TX United States
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