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

Breast Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044993
• Other study ID #: INTROGEN-201-010
• Secondary ID: CDR0000256223MDA
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2002
• Last updated: May 29, 2013
• Start date: February 2002
• Est. completion date: August 2004

Study information

• Verified date: July 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• Ad5CMV-p53 gene

Drug:
• docetaxel

• doxorubicin hydrochloride

Procedure:
• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Introgen Therapeutics

Country where clinical trial is conducted

United States,