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Phase II Study of Docetaxel, Doxorubicin, and Ad5CMV-p53 Gene Therapy (INGN 201) in Patients With Locally Advanced Breast Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Completed 18 and over Pharmaceutical / Industry INTROGEN-201-010
MDA-ID-00008, NCT00044993

Objectives

Determine the therapeutic efficacy of docetaxel, doxorubicin, and Ad5CMV-p53 gene in patients with locally advanced breast cancer.

Entry 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

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

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

Expected Enrollment

A maximum of 60 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Introgen Therapeutics, Incorporated

Jill Van Warthood, PhD, Protocol chair
Ph: 713-610-4034

Registry Information

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)

Trial Start Date		2002-02-11

Registered in ClinicalTrials.gov		NCT00044993

Date Submitted to PDQ		2002-06-19

Information Last Verified		2004-07-16

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.