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

NCT00041626 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2007-09-11

No results posted yet for this study

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.

Conditions

  • Carcinoma, Squamous Cell

Interventions

GENETIC

INGN 201

Sponsors & Collaborators

  • Introgen Therapeutics

    lead INDUSTRY

Principal Investigators

  • Kerstin Menander, MD

  • Julie L Sicam, MT (ASCP) MSHS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00041626 on ClinicalTrials.gov