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.
- Determine the cellular immune response to carcinoembryonic antigen pulsed dendritic
cells in patients with adenocarcinoma of the colon metastatic to the liver.
- Evaluate the overall and recurrence free survival in this patient population.
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.
- Histologically confirmed adenocarcinoma of the colon metastatic to the liver that
expresses carcinoembryonic antigen (CEA) after resection with curative intent
- At least 50% of the tumor cells must stain positive for CEA with at least
- No gross residual disease after surgery
- 18 and over
- Karnofsky 70-100%
- Greater than 6 months
- Absolute neutrophil count at least 1000/mm 3
- Hemoglobin at least 9 g/dL
- Platelet count at least 100,000/mm^3
- Bilirubin less than 2.0 mg/dL
- No chronic or acute hepatic disease
- Creatinine less than 2.5 mg/dL
- No chronic or acute cardiac disease (New York Heart Association class III or IV)
- No chronic or acute pulmonary illness such as asthma or chronic obstructive pulmonary
- Not pregnant or nursing
- 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, ankylosing spondylitis, scleroderma, and multiple sclerosis
- No active acute or chronic infection such as urinary tract infection, HIV, or viral
- No active infectious enteritis or eosinophilic enteritis
PRIOR CONCURRENT THERAPY:
- No other concurrent immunotherapy
- No concurrent chemotherapy
- At least 6 weeks since prior chemotherapy
- No concurrent steroid therapy (or any other immunosuppressives)
- At least 6 weeks since prior steroid therapy
- No concurrent radiotherapy
- At least 6 weeks since prior radiotherapy
- Recovered from prior surgery