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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: Ad5CMV-p53 gene
* Drug: docetaxel
* Drug: doxorubicin hydrochloride
* Procedure: conventional surgery
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Ad5CMV-p53 gene|nan|
|Drug: docetaxel|nan|
|Drug: doxorubicin hydrochloride|nan|
|Procedure: conventional surgery|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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male breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer