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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00041626
Recruitment Status : Unknown
Verified September 2007 by Introgen Therapeutics.
Recruitment status was:  Recruiting
First Posted : July 12, 2002
Last Update Posted : September 11, 2007
Information provided by:

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) 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 or disease Intervention/treatment Phase
Carcinoma, Squamous Cell Genetic: INGN 201 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 18 years or older
  • Must have had radiation treatment
  • Eligible for chemotherapy
  • Not eligible for surgery
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041626

Contact: Introgen Therapeutics, Inc. 866.631.4646 clinicaltrials@introgen.com

United States, Arkansas
University of Arkansas Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Karen Duvall    501-526-7129    kaduvall@uams.edu   
Principal Investigator: James Suen, MD         
United States, Colorado
Unversity of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Brittney Hines    720-848-0678    Brittany.Hines@uchsc.edu   
Principal Investigator: Madeleine Kane, MD         
United States, Florida
University of Miami Hospital and Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Andrea Gachupin-Garcia    305-243-3379    agachupin@med.miami.edu   
Principal Investigator: Jarrad Goodwin, MD         
United States, Kentucky
Norton Healthcare Pavilion Recruiting
Louisville, Kentucky, United States, 40202
Contact: Daniela Neamtu    502-629-4679    daniela.neamtu@nortonhealthcare.org   
Principal Investigator: John Hamm, MD         
United States, Maryland
Center Center of GBMC Recruiting
Baltimore, Maryland, United States, 21204
Contact: Lauren Titus    443-849-3285    ltitus@gbmc.org   
Principal Investigator: Marshall Levine, MD         
United States, South Carolina
WJB Dorn VA Medical Center Recruiting
Columbia, South Carolina, United States, 29209
Contact: Justin Reynolds    803-776-4000 ext 6074    Justin.Reynolds@va.gov   
Principal Investigator: William Hrushesky, MD         
United States, Texas
Mary Crowley Medical Research Center Recruiting
Dallas, Texas, United States, 75201
Contact: Arlen Waclawczyk    214-658-1985    awaclawczyk@mcmrc.com   
Principal Investigator: John Nemunaitis, MD         
University of Texas, MD Andersen Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Aida Berryman    713-745-1428    atberryman@mdanderson.org   
Principal Investigator: Gary Clayman, MD         
Sponsors and Collaborators
Introgen Therapeutics
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
First Posted: July 12, 2002    Key Record Dates
Last Update Posted: September 11, 2007
Last Verified: September 2007

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

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