NCT00044993

Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Introgen Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Ad5CMV-p53 gene
DRUG	docetaxel
DRUG	doxorubicin hydrochloride
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy

Timeline

• Start date: 2002-02-01
• Completion: 2004-08-01
• First posted: 2003-01-27
• Last updated: 2013-05-30

Locations

1 site across 1 country: United States