Back to resultsEffectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
Primary Purpose
Carcinoma, Squamous Cell
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
INGN 201
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Squamous Cell focused on measuring Recurrent Squamous Cell Carcinoma of the Head and Neck
Eligibility Criteria
18 years or older Must have had radiation treatment Eligible for chemotherapy Not eligible for surgery
Sites / Locations
- University of ArkansasRecruiting
- Unversity of Colorado Cancer CenterRecruiting
- University of Miami Hospital and Sylvester Comprehensive Cancer CenterRecruiting
- Norton Healthcare PavilionRecruiting
- Center Center of GBMCRecruiting
- WJB Dorn VA Medical CenterRecruiting
- Mary Crowley Medical Research CenterRecruiting
- University of Texas, MD Andersen Cancer CenterRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00041626
First Posted
July 11, 2002
Last Updated
September 10, 2007
Sponsor
Introgen Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT00041626
Brief Title
Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Introgen Therapeutics
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell
Keywords
Recurrent Squamous Cell Carcinoma of the Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
INGN 201
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
18 years or older
Must have had radiation treatment
Eligible for chemotherapy
Not eligible for surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Introgen Therapeutics, Inc.
Phone
866.631.4646
Email
clinicaltrials@introgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerstin Menander, MD
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julie L Sicam, MT (ASCP) MSHS
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Duvall
Phone
501-526-7129
Email
kaduvall@uams.edu
First Name & Middle Initial & Last Name & Degree
James Suen, MD
Facility Name
Unversity of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittney Hines
Phone
720-848-0678
Email
Brittany.Hines@uchsc.edu
First Name & Middle Initial & Last Name & Degree
Madeleine Kane, MD
Facility Name
University of Miami Hospital and Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Gachupin-Garcia
Phone
305-243-3379
Email
agachupin@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Jarrad Goodwin, MD
Facility Name
Norton Healthcare Pavilion
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Neamtu
Phone
502-629-4679
Email
daniela.neamtu@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
John Hamm, MD
Facility Name
Center Center of GBMC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Titus
Phone
443-849-3285
Email
ltitus@gbmc.org
First Name & Middle Initial & Last Name & Degree
Marshall Levine, MD
Facility Name
WJB Dorn VA Medical Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Reynolds
Phone
803-776-4000
Ext
6074
Email
Justin.Reynolds@va.gov
First Name & Middle Initial & Last Name & Degree
William Hrushesky, MD
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arlen Waclawczyk
Phone
214-658-1985
Email
awaclawczyk@mcmrc.com
First Name & Middle Initial & Last Name & Degree
John Nemunaitis, MD
Facility Name
University of Texas, MD Andersen Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aida Berryman
Phone
713-745-1428
Email
atberryman@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Gary Clayman, MD
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
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