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

NCT ID: NCT00041626

Last Updated: 2007-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Squamous Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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INGN 201

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Not eligible for surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Introgen Therapeutics

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kerstin Menander, MD

Role: STUDY_DIRECTOR

Julie L Sicam, MT (ASCP) MSHS

Role: STUDY_CHAIR

Locations

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University of Arkansas

Little Rock, Arkansas, United States

Site Status RECRUITING

Unversity of Colorado Cancer Center

Aurora, Colorado, United States

Site Status RECRUITING

University of Miami Hospital and Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status RECRUITING

Norton Healthcare Pavilion

Louisville, Kentucky, United States

Site Status RECRUITING

Center Center of GBMC

Baltimore, Maryland, United States

Site Status RECRUITING

WJB Dorn VA Medical Center

Columbia, South Carolina, United States

Site Status RECRUITING

Mary Crowley Medical Research Center

Dallas, Texas, United States

Site Status RECRUITING

University of Texas, MD Andersen Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Introgen Therapeutics, Inc.

Role: CONTACT

866.631.4646

Facility Contacts

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Karen Duvall

Role: primary

501-526-7129

Brittney Hines

Role: primary

720-848-0678

Andrea Gachupin-Garcia

Role: primary

305-243-3379

Daniela Neamtu

Role: primary

502-629-4679

Lauren Titus

Role: primary

443-849-3285

Justin Reynolds

Role: primary

803-776-4000 ext. 6074

Arlen Waclawczyk

Role: primary

214-658-1985

Aida Berryman

Role: primary

713-745-1428

Other Identifiers

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T302

Identifier Type: -

Identifier Source: org_study_id

NCT00040716

Identifier Type: -

Identifier Source: nct_alias