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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jill Van Warthood, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Introgen Therapeutics

Authority:

United States: Federal Government

Study ID:

INTROGEN-201-010

NCT ID:

NCT00044993

Start Date:

February 2002

Completion Date:

August 2004

Related Keywords:

  • Breast Cancer
  • male breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009