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

NCT ID: NCT00044993

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2004-08-31

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Ad5CMV-p53 gene

Intervention Type: BIOLOGICAL

docetaxel

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Introgen Therapeutics

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jill Van Warthood, PhD

Role: STUDY_CHAIR

Introgen Therapeutics

Locations

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

CDR0000256223

Identifier Type: REGISTRY

Identifier Source: secondary_id

MDA-ID-00008

Identifier Type: -

Identifier Source: secondary_id

INTROGEN-201-010

Identifier Type: -

Identifier Source: org_study_id