Immunotherapy in Treating Patients With Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00003432 |
Recruitment Status :
Terminated
(low accrual)
First Posted : April 25, 2003
Last Update Posted : November 6, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 1998 |
Actual Primary Completion Date : | November 2002 |
Actual Study Completion Date : | November 2002 |

Arm | Intervention/treatment |
---|---|
Experimental: carcinoembryonic antigen RNA-pulsed DC cancer vaccine
carcinoembryonic antigen RNA-pulsed DC cancer vaccine
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Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine
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. |
- 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) ]
- 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) ]

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

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 ClinicalTrials.gov identifier (NCT number): NCT00003432
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Herbert K. Lyerly, MD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00003432 |
Other Study ID Numbers: |
2030 IRB 2030 ( Other Identifier: DUMC ) CDR0000066458 ( Other Identifier: NCI ) |
First Posted: | April 25, 2003 Key Record Dates |
Last Update Posted: | November 6, 2013 |
Last Verified: | November 2013 |
stage IV breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |