Spots Global Cancer Trial Database for Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
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Trial Identification
Brief Title: Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
Official Title:
Study ID: NCT00041626
Conditions
Interventions
Study Description
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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas, Little Rock, Arkansas, United States
Unversity of Colorado Cancer Center, Aurora, Colorado, United States
University of Miami Hospital and Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Norton Healthcare Pavilion, Louisville, Kentucky, 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
Contact Details
Name: Kerstin Menander, MD
Affiliation:
Role: STUDY_DIRECTOR
Name: Julie L Sicam, MT (ASCP) MSHS
Affiliation:
Role: STUDY_CHAIR
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