Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT00003433
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003433
Study Brief:
Protocol Section:
NCT00003433