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)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: BCG vaccine Biological: CD80 breast cancer vaccine Biological: sargramostim Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Trial Using a CD80-Modified Allogeneic Breast Cancer Cell Line to Vaccinate HLA-A2-Positive Women With Breast Cancer
Study Start Date : August 1996
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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

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 identifier (NCT number): NCT00003184

United States, Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Sponsors and Collaborators
Providence Cancer Center, Earle A. Chiles Research Institute
Study Chair: Walter J. Urba, MD, PhD Providence Cancer Center, Earle A. Chiles Research Institute

Publications of Results:
Schoof DD, Smith JW, Disis ML, et al.: Immunization of metastatic breast cancer patients with CD80-modified breast cancer cells and GM-CSF. In: Walden P, Trefzer U, Sterry W, et al., eds.: Gene Therapy of Cancer. New York, NY: Plenum Press, 1998, pp 511-518. Identifier: NCT00003184     History of Changes
Other Study ID Numbers: CDR0000066010
First Posted: July 11, 2003    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: November 2000

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic