Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 Treatment
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, dendritic cell, CEA, IL-2
Eligibility Criteria
Inclusion Criteria: Patients must have metastatic colorectal cancer. Patients must have at least one measurable lesion. Patients'serum level of CEA must be higher than 5 times of the normal value Patients'disease must have failed chemotherapy with 5FU, CPT-11 or oxaliplatin. Patients who are unsuitable or refuse chemotherapy will be considered eligible for this trial. Patients'age must be 20 or greater. Patients'estimated life expectancy is more than 3 months. Patients must have adequate bone marrow function, defined as WBC >= 3500/mm3, neutrophil >= 1500/mm3, lymphocyte >= 1,000/mm3, and platelet >= 100,000/mm3. Patients must have adequate liver and renal function, defined as serum alanine transaminase (ALT) and aspartate transaminase (AST) =< 5 times normal, bilirubin =< 1.5 times normal range, and creatinine =< 2 times upper normal limit. All patients should have documentation of negative result of penicillin test. Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. All patients must be informed of the investigational nature of this study and must sign and give written informed consent. Exclusion Criteria: Patients who have central nervous system metastasis except for those whose CNS disease has been treated with radiotherapy and/or surgery and has been stable for at least two weeks Patients who have active acute or chronic infection (at the discretion of the investigator). Pregnant or breast-nursing women Patients who have active cardiac disease requiring therapy for failure, angina, arrythmia, or infarction within the preceding 6 months (exception: any patient whose cardiac failure is compensated on medications) Patients who have asthma Patients who have autoimmune disease such as inflammatory bowel disease, lupus erythematosus, ankylosing spondylitis, scleroderma, and multiple sclerosis Patients who have serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) Patients who have other prior or concurrent malignancy except for in-situ-carcinoma of cervix or adequately treated basal cell carcinoma of skin. Patients who received chemotherapy, steroid or biologic treatment within 4 weeks prior to enrollment
Sites / Locations
- National Taiwan University HospitalRecruiting