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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Locations
- 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •18 and over
- •Male or female
- •Menopausal status
- •Not specified
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Adequate bone marrow function
- •Adequate liver function
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Adequate kidney function
- •Cardiovascular
- •Normal cardiac function by MUGA and/or echocardiogram
- •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
- •Not specified
Exclusion Criteria
- Not provided