A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous, Cultured Dendritic Cells After Complete Resection of Hepatic Metastases of Colorectal Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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
moderate intensity

- No gross residual disease after surgery

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Greater than 6 months

Hematopoietic:

- Absolute neutrophil count at least 1000/mm 3

- Hemoglobin at least 9 g/dL

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL

- No chronic or acute hepatic disease

Renal:

- Creatinine less than 2.5 mg/dL

Cardiovascular:

- No chronic or acute cardiac disease (New York Heart Association class III or IV)

Pulmonary:

- No chronic or acute pulmonary illness such as asthma or chronic obstructive pulmonary
disease

Other:

- 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
hepatitis

- No active infectious enteritis or eosinophilic enteritis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No other concurrent immunotherapy

Chemotherapy:

- No concurrent chemotherapy

- At least 6 weeks since prior chemotherapy

Endocrine therapy:

- No concurrent steroid therapy (or any other immunosuppressives)

- At least 6 weeks since prior steroid therapy

Radiotherapy:

- No concurrent radiotherapy

- At least 6 weeks since prior radiotherapy

Surgery:

- Recovered from prior surgery