Vaccine Therapy in Treating Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003184
Recruitment Status : Completed
First Posted : July 11, 2003
Last Update Posted : April 4, 2013
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
July 11, 2003
April 4, 2013
August 1996
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Complete list of historical versions of study NCT00003184 on Archive Site
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Vaccine Therapy in Treating Women With Metastatic Breast Cancer
Phase I Trial Using a CD80-Modified Allogeneic Breast Cancer Cell Line to Vaccinate HLA-A2-Positive Women With Breast Cancer

RATIONALE: Vaccines made from breast cancer cells may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccines made from breast cancer cells in treating women with metastatic breast cancer.


  • Determine the safety and toxicity of vaccination strategies employing a CD80-transfected allogeneic breast cancer cell line (MDA-MB-231).
  • Assess the immunologic response of lymphocytes isolated from lymph nodes draining the vaccination site following a single dose of CD80-transfected MDA-MB-231.
  • Assess the development of systemic immunity following multiple injections of CD80-transfected MDA-MB-231.
  • Observe for tumor regression.

OUTLINE: This is a dose-escalation study.

Patients receive intradermal vaccinations containing CD80-transfected cells with or without sargramostim (GM-CSF) or with or without BCG. Vaccinations are administered every 2 weeks for 6 weeks and then monthly for 3 months. Patients may receive 1 of 2 different doses of GM-CSF. GM-CSF is administered with the vaccination, then every 12 hours for 7 days. Monthly vaccinations may continue as long as response is shown.

Cohorts of 5 patients each are treated at each dose/combination. Each cohort completes treatment before the next cohort is accrued.

Patients are followed at weeks 4 and 8, then every 2 months for 6 months, then every 3 months for 1 year, and then every 6 months until disease progression.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 18 months.

Phase 1
Primary Purpose: Treatment
Breast Cancer
  • Biological: BCG vaccine
  • Biological: CD80 breast cancer vaccine
  • Biological: sargramostim
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Schoof DD, Smith JW 2nd, Disis ML, Brant-Zawadski P, Wood W, Doran T, Johnson E, Urba WJ. Immunization of metastatic breast cancer patients with CD80-modified breast cancer cells and GM-CSF. Adv Exp Med Biol. 1998;451:511-8.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2003
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  • Histologically proven metastatic breast cancer

    • Stage IV disease patients who have either been treated to maximal response or who have had high dose chemotherapy or a marrow ablative regimen (if they meet immunologic criteria and have not received more than 2 chemotherapy regimens for treatment of metastatic disease)
    • Patients with advanced stage disease who:

      • Received at least 1 standard chemotherapy regimen, but no more than 2, for treatment of metastatic disease
      • Refused chemotherapy
      • Refused or progressed despite hormonal therapy
  • Measurable or evaluable disease
  • Positive or negative for HLA-A2
  • Must have superficial inguinal or axillary lymph nodes that are free of tumor involvement and are surgically accessible
  • No symptomatic or acutely life threatening tumor that is judged likely to require intervention with alternative modalities within 3 months
  • No brain metastases
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • Not specified


  • WBC greater than 3,000/mm^3


  • Not specified


  • BUN less than 25 mg/dL
  • Creatinine less than 1.8 mg/dL


  • No ischemic or congestive cardiac disease requiring chronic medication
  • No New York Heart Association class III or IV heart disease
  • No evidence of ischemic change or ventricular ectopy (greater than 4/min) on electrocardiogram (EKG)
  • No evidence of type II arterial-ventricular block
  • No evidence of current cardiac disease by stress test and EKG


  • HIV negative
  • No active infection requiring treatment
  • No psychiatric illness
  • No history of seizure disorder
  • No other prior malignancy within the past 10 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • At least 4 weeks since prior specific or nonspecific immunotherapy, unless there is obvious progression of metastatic disease, and recovered


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy, unless there is obvious progression of metastatic disease, and recovered

Endocrine therapy:

  • At least 4 weeks since prior steroids, unless there is obvious progression of metastatic disease, and recovered


  • Concurrent radiotherapy allowed for local control of disease


  • Not specified
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Providence Cancer Center, Earle A. Chiles Research Institute
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Study Chair: Walter J. Urba, MD, PhD Providence Cancer Center, Earle A. Chiles Research Institute
National Cancer Institute (NCI)
November 2000

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