Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate - Full Text View

Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate

This study is currently recruiting participants.
Verified by Introgen Therapeutics, March 2008

Sponsored by:	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

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Methotrexate

U.S. FDA Resources

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

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

Study ID Numbers:	T301
First Received:	July 11, 2002
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00041613
Health Authority:	United States: Food and Drug Administration

Keywords provided by Introgen Therapeutics:

Refractory Squamous Cell Carcinoma of the Head and Neck

Study placed in the following topic categories:

Epidermoid carcinoma

Squamous cell carcinoma

Carcinoma, squamous cell

Methotrexate

Neoplasms, Squamous Cell

Carcinoma, Squamous Cell

Carcinoma, squamous cell of head and neck

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 15, 2008