Vaccine Therapy in Treating Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003184
First received: November 1, 1999
Last updated: April 2, 2013
Last verified: November 2000
  Purpose

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 Intervention Phase
Breast Cancer
Biological: BCG vaccine
Biological: CD80 breast cancer vaccine
Biological: sargramostim
Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1996
Study Completion Date: July 2003
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 3,000/mm^3

Hepatic:

  • Not specified

Renal:

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

Cardiovascular:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

  • Concurrent radiotherapy allowed for local control of disease

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003184

Locations
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
Investigators
Study Chair: Walter J. Urba, MD, PhD Providence Cancer Center, Earle A. Chiles Research Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003184     History of Changes
Other Study ID Numbers: CDR0000066010, PPMC-IRB-94-78, OCC-ONC-9408-L, NCI-V98-1379
Study First Received: November 1, 1999
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 21, 2014