Effectiveness and Safety of INGN 201 in Combination With... | NCT00041626

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

NCT00041626

Sponsor

Introgen Therapeutics

Status

Unknown status

Last Update Posted

Sep 11, 2007Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Carcinoma, Squamous Cell

Interventions

INGN 201

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 11, 2002

First Submission Date that Met QC Criteria

Jul 11, 2002

First Posted Date

Jul 12, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2007

Last Update Posted Date

Sep 11, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
INGN 201	Genetic

Eligibility Module

Eligibility Criteria

18 years or older
Must have had radiation treatment
Eligible for chemotherapy
Not eligible for surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Introgen Therapeutics, Inc.	Contact	866.631.4646		clinicaltrials@introgen.com

Overall Officials

Name	Affiliation	Role
Kerstin Menander, MD		Study Director
Julie L Sicam, MT (ASCP) MSHS		Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas	Recruiting	Little Rock	Arkansas	72205	United States

Condition Browse Module

MeSH Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D000077195	Squamous Cell Carcinoma of Head and Neck

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided