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

Phase 3

• Conditions: Carcinoma, Squamous Cell

• Registration Number: NCT00041613
• 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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-07-11
• Study First Submitted QC: 2002-07-11
• Study First Posted: 2002-07-12
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-28
• Last Update Posted: 2008-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (5)

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