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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00027534
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced or metastatic malignancy expressing CEA
* Metastatic disease meeting one of the following criteria:
* Measurable or nonmeasurable
* History of metastases but no current evidence of disease, meeting one of the following criteria:
* Unresectable peritoneal or lymph node metastases that cannot be detected by imaging
* Treated or resected metastatic disease considered at high risk of recurrence (predicted 5-year disease-free survival of less than 50%)
* Must have completed treatment that rendered no evidence of disease within the past year
* CEA-expressing malignancy is defined by any of the following:
* Immunohistochemical staining (at least 50% of the tumor has at least a moderate intensity of staining)
* CEA level in peripheral blood greater than 2.5 µg/L
* Tumor known to be universally CEA positive (e.g., colon and rectal cancer)
* Received prior therapy with possible survival benefit or refused such therapy
* Prior resection of brain metastases allowed provided no metastasis by CT scan or MRI of the brain within 1 month of enrollment
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over Sex
* Male or female Menopausal status
* Not specified Performance status
* Karnofsky 70-100% Life expectancy
* More than 6 months
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute lymphocyte count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) Hepatic
* Bilirubin less than 2.0 mg/dL
* SGOT/SGPT less than 1.5 times upper limit of normal
* No active acute or chronic viral hepatitis
* Hepatitis B surface antigen negative
* Hepatitis C negative
* No other hepatic disease that would preclude study entry
Renal
* Creatinine less than 2.5 mg/dL
* No active acute or chronic urinary tract infection
Cardiovascular
* No New York Heart Association class III or IV heart disease Immunologic
* HIV negative
* No history of autoimmune disease, including, but not limited to, the following:
* Inflammatory bowel disease
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Ankylosing spondylitis
* Scleroderma
* Multiple sclerosis
* No allergy to eggs or any component of study vaccine Other
* No active acute or chronic infection
* No concurrent serious acute or chronic illness that would preclude study entry
* No other medical or psychological impediment that would preclude study entry
* No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior biologic therapy and recovered
* No other concurrent immunotherapy
Chemotherapy
* At least 4 weeks since prior chemotherapy and recovered
* No concurrent chemotherapy
Endocrine therapy
* At least 4 weeks since prior hormonal therapy and recovered
* At least 6 weeks since prior steroids except steroids used as premedication for chemotherapy or for contrast-enhanced studies
* No concurrent steroids
Radiotherapy
* Prior palliative radiotherapy (including systemic radiolabeled compounds) for unstable or painful bone metastases in weight-bearing bones may be allowed
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery
* Not specified
Other
* At least 4 weeks since any other prior therapy (including experimental therapy) and recovered
* No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00027534
Study Brief:
Protocol Section:
NCT00027534