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Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate

NCT ID: NCT00041613

Last Updated: 2008-04-01

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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.

Detailed Description

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Conditions

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Carcinoma, Squamous Cell

Keywords

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Refractory Squamous Cell Carcinoma of the Head and Neck

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

* Must have had radiation and chemotherapy treatments
* No prior methotrexate treatments
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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Unversity of Colorado Cancer Center

Aurora, Colorado, United States

Site Status RECRUITING

Norton Healthcare Pavilion

Louisville, Kentucky, United States

Site Status RECRUITING

Cancer 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

Countries

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United States

Central Contacts

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Introgen Therapeutics, Inc.

Role: CONTACT

Phone: 866.631.4646

Email: [email protected]

Therapeutics, Inc.

Role: CONTACT

Facility Contacts

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Brittney Hines

Role: primary

Daniela Neamtu

Role: primary

Lauren Titus

Role: primary

Justin Reynolds

Role: primary

Arlen Waclawczyk

Role: primary

Other Identifiers

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T301

Identifier Type: -

Identifier Source: org_study_id

NCT00040703

Identifier Type: -

Identifier Source: nct_alias