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

Status unconfirmed · Phase 3

Conditions studied: Carcinoma, Squamous Cell

In brief

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.

Key facts

Study ID

NCT00041626

Run by

Introgen Therapeutics

Last updated by the study team

2007-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of Arkansas — Little Rock, Arkansas, United States (enrolling)
• Unversity of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• University of Miami Hospital and Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• Norton Healthcare Pavilion — Louisville, Kentucky, United States (enrolling)
• Center Center of GBMC — Baltimore, Maryland, United States (enrolling)
• WJB Dorn VA Medical Center — Columbia, South Carolina, United States (enrolling)
• Mary Crowley Medical Research Center — Dallas, Texas, United States (enrolling)
• University of Texas, MD Andersen Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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