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

Carcinoma, Squamous Cell Clinical Trial

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00041626
Study type Interventional
Source Introgen Therapeutics
Contact Introgen Therapeutics, Inc.
Phone 866.631.4646
Email clinicaltrials@introgen.com
Status Recruiting
Phase Phase 3
View Details
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