Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Introgen Therapeutics.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Introgen Therapeutics
Information provided by:
Introgen Therapeutics
ClinicalTrials.gov Identifier:
NCT00041626
First received: July 11, 2002
Last updated: September 10, 2007
Last verified: September 2007
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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 |
Resource links provided by NLM:
Further study details as provided by Introgen Therapeutics:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041626
Contacts
| Contact: Introgen Therapeutics, Inc. | 866.631.4646 | clinicaltrials@introgen.com |
Locations
| 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
Investigators
| Study Director: | Kerstin Menander, MD | |
| Study Chair: | Julie L Sicam, MT (ASCP) MSHS |
More Information
No publications provided
| 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 Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
ClinicalTrials.gov processed this record on June 18, 2013