Breast Cancer Clinical Trial
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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