Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
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ClinicalTrials.gov Identifier: NCT00044993 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: May 30, 2013
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Biological: Ad5CMV-p53 gene Drug: docetaxel Drug: doxorubicin hydrochloride Procedure: conventional surgery Procedure: neoadjuvant therapy | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | February 2002 |
Actual Study Completion Date : | August 2004 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044993
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Jill Van Warthood, PhD | Introgen Therapeutics |
ClinicalTrials.gov Identifier: | NCT00044993 History of Changes |
Other Study ID Numbers: |
INTROGEN-201-010 CDR0000256223 ( Registry Identifier: PDQ (Physician Data Query) ) MDA-ID-00008 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | May 30, 2013 |
Last Verified: | July 2004 |
Keywords provided by National Cancer Institute (NCI):
male breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Docetaxel Liposomal doxorubicin Doxorubicin Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |