Back to resultsStudy to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate
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 Refractory Squamous Cell Carcinoma of the Head and Neck
Eligibility Criteria
18 years or older Not eligible for surgery Must have had radiation and chemotherapy treatments No prior methotrexate treatments
Sites / Locations
- Unversity of Colorado Cancer CenterRecruiting
- Norton Healthcare PavilionRecruiting
- Cancer Center of GBMCRecruiting
- WJB Dorn VA Medical CenterRecruiting
- Mary Crowley Medical Research CenterRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00041613
Brief Title
Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell
Keywords
Refractory 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
Not eligible for surgery
Must have had radiation and chemotherapy treatments
No prior methotrexate treatments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Introgen Therapeutics, Inc.
Phone
866.631.4646
Email
clinicaltrials@introgen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Therapeutics, Inc.
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
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
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
Cancer 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
12. IPD Sharing Statement
Learn more about this trial
Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate
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