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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT00023933
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed metastatic adenocarcinoma of the colon or rectum
* Not amenable to surgical resection
* Recurrent or persistent disease after standard surgery, radiotherapy, and chemotherapy, including fluorouracil and irinotecan
* TAG-72 positive
* Performance status - ECOG 0-2
* WBC greater than 3,500/mm\^3
* Platelet count greater than 125,000/mm\^3
* Hemoglobin greater than 10 g/dL
* No nucleated RBC or significant teardrop RBC morphology
* Bilirubin less than 1.5 mg/dL
* SGOT/SGPT less than 4 times normal
* Hepatitis B surface antigen negative
* Creatinine less than 2.0 mg/dL
* HIV negative
* No other malignancy within the past 5 years except basal cell skin cancer
* No allergy to iodine
* No detectable antibody to monoclonal antibody CC49
* Not pregnant or nursing
* Fertile patients must use effective contraception
* At least 3 weeks since prior immunotherapy and recovered
* No prior bone marrow or stem cell transplantation
* No other concurrent immunotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered
* No concurrent chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to more than 25% of red marrow
* No concurrent radiotherapy
* See Disease Characteristics
* At least 3 weeks since prior surgery and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00023933
Study Brief:
Protocol Section:
NCT00023933