Breast Cancer Clinical Trial
Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
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.
Full 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.
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
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There is 1 Location for this study
Houston Texas, 77030, United States
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