Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
- Conditions
- Carcinoma, Squamous Cell
- Registration Number
- NCT00041626
- Lead Sponsor
- Introgen Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
University of Miami Hospital and Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Center Center of GBMC
🇺🇸Baltimore, Maryland, United States
WJB Dorn VA Medical Center
🇺🇸Columbia, South Carolina, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
University of Texas, MD Andersen Cancer Center
🇺🇸Houston, Texas, United States
Unversity of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Norton Healthcare Pavilion
🇺🇸Louisville, Kentucky, United States