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NCT00041613 Clinical Trial

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

Carcinoma, Squamous Cell Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00041613
Other study ID # T301
Secondary ID
Status Recruiting
Phase Phase 3
First received July 11, 2002
Last updated March 28, 2008

Study information
Verified date March 2008
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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.

Other known NCT identifiers
  • NCT00040703

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

- Not eligible for surgery

- Must have had radiation and chemotherapy treatments

- No prior methotrexate treatments

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 Cancer 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 Norton Healthcare Pavilion Louisville Kentucky

Sponsors (1)
Lead Sponsor Collaborator
Introgen Therapeutics

Country where clinical trial is conducted

United States, 

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