Spots Global Cancer Trial Database for Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate
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Trial Identification
Brief Title: Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate
Official Title:
Study ID: NCT00041613
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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Unversity of Colorado Cancer Center, Aurora, Colorado, United States
Norton Healthcare Pavilion, Louisville, Kentucky, United States
Cancer 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
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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