A Phase 1/2 interventional study of carcinoembryonic antigen RNA-pulsed DC cancer vaccine in Colorectal Cancer and Metastatic Cancer, sponsored by Duke Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-21.
Sponsored by Duke Cancer Institute · Phase 1/2, Interventional, and Treatment
RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to 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 resected liver metastases from colon cancer.
OBJECTIVES:
OUTLINE: Patients undergo leukapheresis for up to 4.5 hours to collect dendritic cells. The separated dendritic cells are pulsed with carcinoembryonic antigen (CEA) RNA. Patients receive CEA RNA pulsed dendritic cells intravenously every 2 weeks for a total of 4 doses. Patients undergo a second leukapheresis 2 weeks after the last dendritic cell infusion to obtain specimens for immunologic tests. Patients with extra doses of dendritic cells available may receive additional doses of CEA RNA pulsed dendritic cells every 2 months in the absence of unacceptable toxicity.
Patients are followed at weeks 12, 24, 36, and 48, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study over 2 years.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
Browse Colorectal Neoplasms studies →This is the only study on the registry with Duke Cancer Institute as lead sponsor.
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon metastatic to the liver that expresses carcinoembryonic antigen (CEA) after resection with curative intent
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
This study is completed, as verified in Nov 2002. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Carcinoembryonic Antigen RNA-pulsed DC Cancer Vaccine