Recruiting

Phase 3

INGN 201 & ChemotherapyEffectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone

Sponsor:

Introgen Therapeutics

Code:

NCT00041626

Conditions

Carcinoma, Squamous Cell

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INGN 201

Study Details

Brief summary:

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.

Conditions

Carcinoma, Squamous Cell

Study ID

NCT00041626

Status verified date

Sep, 2007

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

18 years or older
Must have had radiation treatment
Eligible for chemotherapy
Not eligible for surgery

Study Design

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

INGN 201

Central Contacts and Locations

Central contacts

Introgen Therapeutics, Inc.

866.631.4646 clinicaltrials@introgen.com

Locations

University of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Karen Duvall

501-526-7129 kaduvall@uams.edu

Principal Investigator:

James Suen, MD

Unversity of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Brittney Hines

720-848-0678 Brittany.Hines@uchsc.edu

Principal Investigator:

Madeleine Kane, MD

University of Miami Hospital and Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Andrea Gachupin-Garcia

305-243-3379 agachupin@med.miami.edu

Principal Investigator:

Jarrad Goodwin, MD

Norton Healthcare Pavilion

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Daniela Neamtu

502-629-4679 daniela.neamtu@nortonhealthcare.org

Principal Investigator:

John Hamm, MD

Center Center of GBMC

Recruiting

Baltimore, Maryland, United States, 21204

Contacts

Lauren Titus

443-849-3285 ltitus@gbmc.org

Principal Investigator:

Marshall Levine, MD

WJB Dorn VA Medical Center

Recruiting

Columbia, South Carolina, United States, 29209

Contacts

Justin Reynolds

803-776-4000 Justin.Reynolds@va.gov

Principal Investigator:

William Hrushesky, MD

Mary Crowley Medical Research Center

Recruiting

Dallas, Texas, United States, 75201

Contacts

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

Contacts

Aida Berryman

713-745-1428 atberryman@mdanderson.org

Principal Investigator:

Gary Clayman, MD

More Information

Sponsor

Introgen Therapeutics

Last update posted

Sep 11, 2007

Last verified

Sep, 2007

Keywords

Recurrent Squamous Cell Carcinoma of the Head and Neck

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Introgen Therapeutics on 2007-09-11.