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Not listed Phase 3 Interventional

Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone

ClinicalTrials.gov ID: NCT00041626

Public ClinicalTrials.gov record NCT00041626. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00041626
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Introgen Therapeutics
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

Genetic

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
Sep 10, 2007

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
University of Arkansas Little Rock Arkansas 72205 Recruiting
Unversity of Colorado Cancer Center Aurora Colorado 80045 Recruiting
University of Miami Hospital and Sylvester Comprehensive Cancer Center Miami Florida 33136 Recruiting
Norton Healthcare Pavilion Louisville Kentucky 40202 Recruiting
Center Center of GBMC Baltimore Maryland 21204 Recruiting
WJB Dorn VA Medical Center Columbia South Carolina 29209 Recruiting
Mary Crowley Medical Research Center Dallas Texas 75201 Recruiting
University of Texas, MD Andersen Cancer Center Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00041626, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 10, 2007 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00041626 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →