Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00044993


Primary Contact:

Study Chair
Jill Van Warthood, PhD
Introgen Therapeutics


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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