Chemotherapy Combined With Gene Therapy in Treating Patie... | NCT00044993

Studies
Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer

NCT00044993

Sponsor

Introgen Therapeutics

Status

Completed

Last Update Posted

May 30, 2013Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Ad5CMV-p53 gene
docetaxel
doxorubicin hydrochloride
conventional surgery
neoadjuvant therapy

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

ID	Type	Description	Link
CDR0000256223	Registry Identifier	PDQ (Physician Data Query)
MDA-ID-00008

Status Module

Record Verification Date

Jul 2004

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2002

Primary Completion Date

Not provided

Completion Date

Aug 2004Actual

First Submitted Date

Sep 6, 2002

First Submission Date that Met QC Criteria

Jan 26, 2003

First Posted Date

Jan 27, 2003Estimated

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

May 29, 2013

Last Update Posted Date

May 30, 2013Estimated

Description Module

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the p53 gene into the tumor may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. Combining chemotherapy with gene therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gene therapy in treating patients who have stage III or stage IV breast cancer.

Detailed Description

OBJECTIVES:

Determine the therapeutic efficacy of docetaxel, doxorubicin, and Ad5CMV-p53 gene in patients with locally advanced breast cancer.

OUTLINE: Patients receive p53 gene by intralesional injection on days 1 and 2. Patients also receive doxorubicin IV over 15 minutes followed 1 hour later by docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses. After completion of chemotherapy, patients with a reasonable response undergo surgical resection.

PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.

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 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer
- Stage IIIA, IIIB (excluding inflammatory breast carcinoma), or IIIC OR
- Localized stage IV
Measurable disease
No metastases
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Male or female

Menopausal status

Not specified

Performance status

Karnofsky 70-100%

Life expectancy

Not specified

Hematopoietic

Adequate bone marrow function

Hepatic

Adequate liver function
Hepatitis B surface antigen negative
Hepatitis C antibody negative

Renal

Adequate kidney function

Cardiovascular

Normal cardiac function by MUGA and/or echocardiogram

Other

No psychological, familial, sociological, or geographical conditions that would preclude study
Not pregnant or nursing
Fertile patients must use effective barrier method of contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior gene therapy using adenoviral vectors or p53 gene product

Chemotherapy

No prior chemotherapy for breast cancer

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

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

ID	Term
D001943	Breast Neoplasms
D018567	Breast Neoplasms, Male

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
C512972	advexin
D000077143	Docetaxel
D004317	Doxorubicin
D020360	Neoadjuvant Therapy

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Name	Type	Description	Arm Group Labels	Other Names
Ad5CMV-p53 gene	Biological
docetaxel	Drug
doxorubicin hydrochloride	Drug
conventional surgery	Procedure
neoadjuvant therapy	Procedure