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

September 10, 2007 updated by: Introgen Therapeutics

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 Overview

Status

Unknown

Conditions

Carcinoma, Squamous Cell

Intervention / Treatment

Genetic: INGN 201

Study Type

Interventional

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - University of Arkansas
    - Contact:
      
      Karen Duvall
      
      Phone Number: 501-526-7129
      
      Email: kaduvall@uams.edu
    - Principal Investigator:
      
      James Suen, MD
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Unversity of Colorado Cancer Center
    - Contact:
      
      Brittney Hines
      
      Phone Number: 720-848-0678
      
      Email: Brittany.Hines@uchsc.edu
    - Principal Investigator:
      
      Madeleine Kane, MD
- Florida
  - Miami, Florida, United States, 33136
    - Recruiting
    - University of Miami Hospital and Sylvester Comprehensive Cancer Center
    - Contact:
      
      Andrea Gachupin-Garcia
      
      Phone Number: 305-243-3379
      
      Email: agachupin@med.miami.edu
    - Principal Investigator:
      
      Jarrad Goodwin, MD
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - Norton Healthcare Pavilion
    - Contact:
      
      Daniela Neamtu
      
      Phone Number: 502-629-4679
      
      Email: daniela.neamtu@nortonhealthcare.org
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Recruiting
    - Center Center of GBMC
    - Contact:
      
      Lauren Titus
      
      Phone Number: 443-849-3285
      
      Email: ltitus@gbmc.org
    - Principal Investigator:
      
      Marshall Levine, MD
- South Carolina
  - Columbia, South Carolina, United States, 29209
    - Recruiting
    - WJB Dorn VA Medical Center
    - Contact:
      
      Justin Reynolds
      
      Phone Number: 6074 803-776-4000
      
      Email: justin.reynolds@va.gov
    - Principal Investigator:
      
      William Hrushesky, MD
- Texas
  - Dallas, Texas, United States, 75201
    - Recruiting
    - Mary Crowley Medical Research Center
    - Contact:
      
      Arlen Waclawczyk
      
      Phone Number: 214-658-1985
      
      Email: awaclawczyk@mcmrc.com
    - Principal Investigator:
      
      John Nemunaitis, MD
  - Houston, Texas, United States, 77030
    - Recruiting
    - University of Texas, MD Andersen Cancer Center
    - Contact:
      
      Aida Berryman
      
      Phone Number: 713-745-1428
      
      Email: atberryman@mdanderson.org
    - Principal Investigator:
      
      Gary Clayman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

18 years or older
Must have had radiation treatment
Eligible for chemotherapy
Not eligible for surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Introgen Therapeutics

Investigators

Study Director: Kerstin Menander, MD
Study Chair: Julie L Sicam, MT (ASCP) MSHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 11, 2002

First Submitted That Met QC Criteria

July 11, 2002

First Posted (Estimate)

July 12, 2002

Study Record Updates

Last Update Posted (Estimate)

September 11, 2007

Last Update Submitted That Met QC Criteria

September 10, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Recurrent Squamous Cell Carcinoma of the Head and Neck

Additional Relevant MeSH Terms

Other Study ID Numbers

T302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.