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)
- 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.
Masking: Open Label, Primary Purpose: Treatment
Jill Van Warthood, PhD
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|