Immunotherapy in Treating Patients With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine
- Registration Number
- NCT00003432
- Lead Sponsor
- Duke University
- Brief 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description carcinoembryonic antigen RNA-pulsed DC cancer vaccine carcinoembryonic antigen RNA-pulsed DC cancer vaccine carcinoembryonic antigen RNA-pulsed DC cancer vaccine
- Primary Outcome Measures
Name Time Method 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. Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)
- Secondary Outcome Measures
Name Time Method Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population. Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)
Trial Locations
- Locations (1)
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States