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

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: NCT00041613
Recruitment Status : Unknown
Verified March 2008 by Introgen Therapeutics.
Recruitment status was:  Recruiting
First Posted : July 12, 2002
Last Update Posted : April 1, 2008
Sponsor:
Information provided by:
Introgen Therapeutics

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 18 years or older
  • Not eligible for surgery
  • Must have had radiation and chemotherapy treatments
  • No prior methotrexate treatments
Contacts and Locations
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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): NCT00041613


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

Locations
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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, 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
Cancer 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         
Sponsors and Collaborators
Introgen Therapeutics
Investigators
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Study Director: Kerstin Menander, MD
Study Chair: Julie L Sicam, MT (ASCP) MSHS
More Information
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ClinicalTrials.gov Identifier: NCT00041613    
Obsolete Identifiers: NCT00040703
Other Study ID Numbers: T301
First Posted: July 12, 2002    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008
Keywords provided by Introgen Therapeutics:
Refractory Squamous Cell Carcinoma of the Head and Neck
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell