Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate

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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.

Key facts

Study ID

NCT00041613

Run by

Introgen Therapeutics

Last updated by the study team

2008-04-01

Who can join

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

Where it is running

• Unversity of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• Norton Healthcare Pavilion — Louisville, Kentucky, United States (enrolling)
• Cancer 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)

Full record on ClinicalTrials.gov

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