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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Introgen Therapeutics
• Treatments: Docetaxel; Doxorubicin; Liposomal doxorubicin

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