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

Date de début de l'étude : 1 juin 1998

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