NCT00041613

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2002

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

First QC Date

July 11, 2002

Last Update Submit

March 28, 2008

Conditions

Carcinoma, Squamous Cell

Keywords

Refractory Squamous Cell Carcinoma of the Head and Neck

Interventions

INGN 201GENETIC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 18 years or older * Not eligible for surgery * Must have had radiation and chemotherapy treatments * No prior methotrexate treatments

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Unversity of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

Norton Healthcare Pavilion

Louisville, Kentucky, 40202, United States

RECRUITING

Cancer Center of GBMC

Baltimore, Maryland, 21204, United States

RECRUITING

WJB Dorn VA Medical Center

Columbia, South Carolina, 29209, United States

RECRUITING

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous CellSquamous Cell Carcinoma of Head and Neck

Interventions

advexin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Kerstin Menander, MD

    STUDY DIRECTOR

  • Julie L Sicam, MT (ASCP) MSHS

    STUDY CHAIR

Central Study Contacts

Introgen Therapeutics, Inc.

CONTACT

866.631.4646clinicaltrials@introgen.com

Therapeutics, Inc.

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2002

First Posted

July 12, 2002

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

US(5)