Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Introgen Therapeutics.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Introgen Therapeutics
Information provided by:
Introgen Therapeutics
ClinicalTrials.gov Identifier:
NCT00041613
First received: July 11, 2002
Last updated: March 28, 2008
Last verified: March 2008
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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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.
| 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:
Genetic and Rare Diseases Information Center resources:
Squamous Cell Carcinoma of the Head and Neck
U.S. FDA Resources
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
- Not eligible for surgery
- Must have had radiation and chemotherapy treatments
- No prior methotrexate treatments
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041613
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041613
Contacts
| Contact: Introgen Therapeutics, Inc. | 866.631.4646 | clinicaltrials@introgen.com | |
| Contact: Therapeutics, Inc. |
Locations
| 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
| Study Director: | Kerstin Menander, MD | ||
| Study Chair: | Julie L Sicam, MT (ASCP) MSHS |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00041613 History of Changes |
| Obsolete Identifiers: | NCT00040703 |
| Other Study ID Numbers: | T301 |
| Study First Received: | July 11, 2002 |
| Last Updated: | March 28, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Introgen Therapeutics:
|
Refractory Squamous Cell Carcinoma of the Head and Neck |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Carcinoma Neoplasms |
Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell |
ClinicalTrials.gov processed this record on March 02, 2015