Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone

Phase 3

• 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

Study Timeline

• Study First Submitted: 2002-07-11
• Study First Submitted QC: 2002-07-11
• Study First Posted: 2002-07-12
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-10
• Last Update Posted: 2007-09-11

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 (8)

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