Breast CancerPhase 1/2NCT00003432
Immunotherapy in Treating Patients With Metastatic Breast Cancer
A Phase 1/2 study testing carcinoembryonic antigen RNA-pulsed DC cancer vaccine in people with Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to and kill their tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with metastatic breast cancer who have achieved a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- carcinoembryonic antigen RNA-pulsed DC cancer vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1998to Nov 2002
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic breast cancer that expresses carcinoembryonic antigen (CEA)
- At least 25% of the tumor cells must stain positive for CEA with at least moderate intensity
- Must have achieved either partial response or complete response after high dose chemotherapy and peripheral blood stem cell transplant
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Menopausal status:
- Not specified
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Greater than 6 months
Hematopoietic:
- Absolute neutrophil count at least 1000/mm^3
- Absolute lymphocyte count at least 1000/mm^3
- Hemoglobin at least 9 mg/dL
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL
- No serious ongoing chronic or acute hepatic disease
Renal:
- Creatinine less than 2.5 mg/dL
Cardiovascular:
- No serious ongoing chronic or acute cardiac disease (New York Heart Association class III or IV)
Pulmonary:
- No serious ongoing chronic or acute pulmonary illness such as asthma, chronic obstructive pulmonary disease, or radiation or drug induced pneumonitis
Other:
- No other prior or concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years
- No history of autoimmune disease such as inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis
- No inflammatory bowel condition such as active infectious enteritis or eosinophilic enteritis
- No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No concurrent immunotherapy
Chemotherapy:
- See Disease Characteristics
- No concurrent chemotherapy
Endocrine therapy:
- At least 4 weeks since steroids
- No concurrent steroid therapy
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No concurrent immunosuppressive agents such as azathioprine or cyclosporine A
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
Official title: A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous Cultured Dendritic Cells for Patients With Breast Cancer Who Achieve a Complete Response After High Dose Chemotherapy and Stem Cell Support
RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to and kill their tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with metastatic breast cancer who have achieved a partial or complete response after chemotherapy and peripheral stem cell transplantation.
Read the detailed description
OBJECTIVES:
- Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.
- Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.
OUTLINE: Dendritic cells are taken from the leukapheresis product obtained during the peripheral blood stem cell transplant procedure performed prior to treatment on this study. The dendritic cells are pulsed with carcinoembryonic antigen (CEA) RNA. Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses. Patients undergo a second leukopheresis after the last dose of immunotherapy to obtain specimens for immunologic tests.
Patients are followed every 3 months for the first year and annually thereafter.
PROJECTED ACCRUAL: A total of 14-26 patients will be accrued for this study within 2 years.
- Conditions
- Breast Cancer
- Being tested
- carcinoembryonic antigen RNA-pulsed DC cancer vaccine
- Keywords
- stage IV 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.
carcinoembryonic antigen RNA-pulsed DC cancer vaccineBiological
Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| carcinoembryonic antigen RNA-pulsed DC cancer vaccine | Experimental | carcinoembryonic antigen RNA-pulsed DC cancer vaccine Receives: Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.
Measured: Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)
Secondary outcomes (1)
Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.
Measured: Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2003 (estimated)
- Study startJun 1998
- Primary completionNov 2002
- Study completionNov 2002
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Herbert K. Lyerly, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003432
- Sponsor's protocol ID
- 2030
- Other IDs
- IRB 2030, CDR0000066458
- Status last verified
- Nov 2013
- First submitted
- 1 Nov 1999
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous Cultured Dendritic Cells for Patients With Breast Cancer Who Achieve a Complete Response After High Dose Chemotherapy and Stem Cell Support
- ClinicalTrials.gov ID
- NCT00003432
- Acronym / sponsor ID
- 2030
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 1998
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 25 Apr 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: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to and kill their tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with metastatic breast cancer who have achieved a partial or complete response after chemotherapy and peripheral stem cell transplantation.
Detailed description
OBJECTIVES:
- Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.
- Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.
OUTLINE: Dendritic cells are taken from the leukapheresis product obtained during the peripheral blood stem cell transplant procedure performed prior to treatment on this study. The dendritic cells are pulsed with carcinoembryonic antigen (CEA) RNA. Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses. Patients undergo a second leukopheresis after the last dose of immunotherapy to obtain specimens for immunologic tests.
Patients are followed every 3 months for the first year and annually thereafter.
PROJECTED ACCRUAL: A total of 14-26 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carcinoembryonic antigen RNA-pulsed DC cancer vaccine | Experimental | Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccinecarcinoembryonic antigen RNA-pulsed DC cancer vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| carcinoembryonic antigen RNA-pulsed DC cancer vaccineApproximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses. | Biological | carcinoembryonic antigen RNA-pulsed DC cancer vaccine |
Primary outcome
Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.
Time frame: Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)
1 secondary outcome
Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.
Time frame: Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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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.
Herbert K. Lyerly, MD study chair
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing carcinoembryonic antigen RNA-pulsed DC cancer vaccine in people with Breast Cancer, run by Duke University 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: stopped early, as of the sponsor's last update on 6 Nov 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: low accrual). Results are not available in the source record.
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.
What does the primary outcome measure?
Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant. (time frame: Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2013.