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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by Introgen Therapeutics.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Introgen Therapeutics
ClinicalTrials.gov Identifier:
NCT00041626
First received: July 11, 2002
Last updated: September 10, 2007
Last verified: September 2007
  Purpose
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.

Condition Intervention Phase
Carcinoma, Squamous Cell
Genetic: INGN 201
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Introgen Therapeutics:

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 18 years or older
  • Must have had radiation treatment
  • Eligible for chemotherapy
  • Not eligible for surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041626

Locations
United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72205
United States, Colorado
Unversity of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami Hospital and Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Kentucky
Norton Healthcare Pavilion
Louisville, Kentucky, United States, 40202
United States, Maryland
Center Center of GBMC
Baltimore, Maryland, United States, 21204
United States, South Carolina
WJB Dorn VA Medical Center
Columbia, South Carolina, United States, 29209
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201
University of Texas, MD Andersen Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Introgen Therapeutics
Investigators
Study Director: Kerstin Menander, MD
Study Chair: Julie L Sicam, MT (ASCP) MSHS
  More Information

ClinicalTrials.gov Identifier: NCT00041626     History of Changes
Obsolete Identifiers: NCT00040716
Other Study ID Numbers: T302 
Study First Received: July 11, 2002
Last Updated: September 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Introgen Therapeutics:
Recurrent Squamous Cell Carcinoma of the Head and Neck

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on December 02, 2016