Trial | NCT00044993  Report issue

Title

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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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.
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 Started
Feb 28
2002
Study Completion
Aug 31
2004
Last Update
May 30
2013
Estimate

Biological Ad5CMV-p53 gene

Drug docetaxel

Drug doxorubicin hydrochloride

Procedure conventional surgery

Procedure neoadjuvant therapy

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
No Results Posted