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OpenTrials
Completed

NCT Number: NCT00044993

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Neoplasms, Male Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ad5CMV-p53 gene

Biological

docetaxel

Drug

Doxorubicin hydrochloride

Drug

conventional surgery

Procedure

neoadjuvant therapy

Procedure

Sponsors and collaborators

Lead sponsor

Introgen Therapeutics

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Study completion
2004
First posted
Jan 27, 2003
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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