Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
NCT00044993 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2013-05-30
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.
Conditions
Interventions
- BIOLOGICAL
-
Ad5CMV-p53 gene
- DRUG
- DRUG
-
doxorubicin hydrochloride
- PROCEDURE
-
conventional surgery
- PROCEDURE
-
neoadjuvant therapy
Sponsors & Collaborators
-
Introgen Therapeutics
lead INDUSTRY
Principal Investigators
-
Jill Van Warthood, PhD · Introgen Therapeutics
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-02-28
- Completion
- 2004-08-31
Countries
- United States
Study Locations
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