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Sponsored by: |
Introgen Therapeutics |
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Information provided by: | Introgen Therapeutics |
ClinicalTrials.gov Identifier: | NCT00041613 |
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 | Intervention | Phase |
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Carcinoma, Squamous Cell |
Genetic: INGN 201 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Contact: Introgen Therapeutics, Inc. | 866.631.4646 | clinicaltrials@introgen.com |
Contact: Therapeutics, Inc. |
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 |
Study Director: | Kerstin Menander, MD | |
Study Chair: | Julie L Sicam, MT (ASCP) MSHS |
Study ID Numbers: | T301 |
Study First Received: | July 11, 2002 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00041613 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Refractory Squamous Cell Carcinoma of the Head and Neck |
Epidermoid Carcinoma Carcinoma, Squamous Cell of Head and Neck Methotrexate Neoplasms, Squamous Cell |
Squamous Cell Carcinoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Squamous Cell |
Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |