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.
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
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.
- First posted11 Jul 2003 (estimated)
- Study startAug 1996
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Providence Cancer Center, Earle A. Chiles Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Walter J. Urba, MD, PhD, Study chair, Providence Cancer Center, Earle A. Chiles Research Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial Using a CD80-Modified Allogeneic Breast Cancer Cell Line to Vaccinate HLA-A2-Positive Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00003184
- Acronym / sponsor ID
- CDR0000066010
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Providence Cancer Center, Earle A. Chiles Research InstituteUniversity, hospital or other
- Study start
- Aug 1996
- Study completion
- Jul 2003 (actual)
- First posted
- 11 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG vaccine | Biological | – |
| CD80 breast cancer vaccine | Biological | – |
| sargramostim | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Results publication: PubMed 10026920Schoof 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter J. Urba, MD, PhD study chair
Providence Cancer Center, Earle A. Chiles Research Institute
1 site in 1 country: see every site and its status.
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.