Recruiting

Phase 3

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

Sponsor:

Introgen Therapeutics

Code:

NCT00041613

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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.

Conditions

Carcinoma, Squamous Cell

Study ID

NCT00041613

Status verified date

Mar, 2008

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

18 years or older
Not eligible for surgery
Must have had radiation and chemotherapy treatments
No prior methotrexate treatments

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

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

Norton Healthcare Pavilion

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Daniela Neamtu

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

Principal Investigator:

John Hamm, MD

Cancer 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

More Information

Sponsor

Introgen Therapeutics

Last update posted

Apr 1, 2008

Last verified

Mar, 2008

Keywords

Refractory Squamous Cell Carcinoma of the Head and Neck

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Introgen Therapeutics on 2008-04-01.