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NCT00041626 Clinical Trial

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

Carcinoma, Squamous Cell Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00041626
Other study ID # T302
Secondary ID
Status Recruiting
Phase Phase 3
First received July 11, 2002
Last updated September 10, 2007

Study information
Verified date September 2007
Source Introgen Therapeutics
Contact Introgen Therapeutics, Inc.
Phone 866.631.4646
Email clinicaltrials@introgen.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Other known NCT identifiers
  • NCT00040716

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - 18 years or older

- Must have had radiation treatment

- Eligible for chemotherapy

- Not eligible for surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Genetic:
• INGN 201

Locations
Country Name City State
United States Unversity of Colorado Cancer Center Aurora Colorado
United States Center Center of GBMC Baltimore Maryland
United States WJB Dorn VA Medical Center Columbia South Carolina
United States Mary Crowley Medical Research Center Dallas Texas
United States University of Texas, MD Andersen Cancer Center Houston Texas
United States University of Arkansas Little Rock Arkansas
United States Norton Healthcare Pavilion Louisville Kentucky
United States University of Miami Hospital and Sylvester Comprehensive Cancer Center Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
Introgen Therapeutics

Country where clinical trial is conducted

United States, 

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