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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


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

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Introgen Therapeutics
Investigators
Study Chair: Jill Van Warthood, PhD Introgen Therapeutics
More Information
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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