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

Tracking Information

First Received Date ^ICMJE

September 6, 2002

Last Updated Date

February 6, 2009

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00044993 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief 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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Biological: Ad5CMV-p53 gene
Drug: docetaxel
Drug: doxorubicin hydrochloride
Procedure: conventional surgery
Procedure: neoadjuvant therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00044993

Responsible Party

Study ID Numbers ^ICMJE

CDR0000256223, INTROGEN-201-010, MDA-ID-00008

Study Sponsor ^ICMJE

Introgen Therapeutics

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Jill Van Warthood, PhD

Introgen Therapeutics

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP