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

First Received on July 11, 2002. Last Updated on March 28, 2008 History of Changes

Sponsor:	Introgen Therapeutics
Information provided by:	Introgen Therapeutics
ClinicalTrials.gov Identifier:	NCT00041613

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 III

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:

MedlinePlus related topics: Cancer

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

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
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on February 09, 2012