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Breast CancerPhase 1NCT00003184

Vaccine Therapy in Treating Women With Metastatic Breast Cancer

A Phase 1 study testing BCG vaccine, CD80 breast cancer vaccine and sargramostim in people with Breast Cancer, run by Providence Cancer Center, Earle A. Chiles Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
BCG vaccine, CD80 breast cancer vaccine and sargramostim
Type of treatment
Vaccines
How many people
Not given
Where
1 siteUnited States
Study dates
Aug 1996to Jul 2003
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Earle A. Chiles Research Institute at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
BCG vaccine, CD80 breast cancer vaccine, sargramostim
Keywords
stage IV breast cancer, recurrent breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCG vaccineBiological

  • CD80 breast cancer vaccineBiological

  • sargramostimBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2003 (estimated)
  2. Study startAug 1996
  3. Study completionJul 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003184
Sponsor's protocol ID
CDR0000066010
Other IDs
PPMC-IRB-94-78, OCC-ONC-9408-L, NCI-V98-1379
Status last verified
Nov 2000
First submitted
1 Nov 1999
Last updated
4 Apr 2013
Results posted
No

Publications

  • 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. doi: 10.1007/978-1-4615-5357-1_79. No abstract available.

    PubMed 10026920

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCG vaccine, CD80 breast cancer vaccine and sargramostim in people with Breast Cancer, run by Providence Cancer Center, Earle A. Chiles Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003184, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.

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