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| Sponsor: | Introgen Therapeutics |
|---|---|
| Information provided by: | Introgen Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00041626 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations| 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 | |
| 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 | |
| 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 |
More Information
| Study ID Numbers: | T302 |
| Study First Received: | July 11, 2002 |
| Last Updated: | September 10, 2007 |
| ClinicalTrials.gov Identifier: | NCT00041626 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Recurrent Squamous Cell Carcinoma of the Head and Neck |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Squamous Cell |
Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |
