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

Phase II, Single Arm, Single Institution Clinical Trial of Docetaxel and Doxorubicin in Combination With Local Administration of INGN 201 (Ad5CMV-p53) in Locally Advanced Breast Cancer (LABC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00044993

Enrollment

Unknown

Registered

2003-01-27

Start date

2002-02-28

Completion date

2004-08-31

Last updated

2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

male breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer

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.

Interventions

BIOLOGICALAd5CMV-p53 gene

DRUGdocetaxel

DRUGdoxorubicin hydrochloride

PROCEDUREconventional surgery

PROCEDUREneoadjuvant therapy

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026