An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer

Korábbi kezelés

• Patients must not have received prior chemotherapy or radiation for \>= 2 weeks before study enrollment
• Pregnant women are excluded from this study because 124I-M5A is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 124I-M5A, breastfeeding should be discontinued if the mother is treated with 124I-M5A
• Any patient who has had exposure to mouse, chimeric (human/mouse) or humanized immunoglobulin and has antibody to the M5A

Más betegség

• Patients should not have any uncontrolled illness including ongoing or active infection
• Patients who have allergy to iodine or iodine contrast agents are not eligible for this protocol
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 124I-M5A

Egyéb

• Patients with single (= 1) liver metastasis are not eligible for this protocol
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

• Patients must have histologically confirmed metastatic colorectal cancer with liver metastases. NOTE: We are not requiring proof of CEA positive disease because \> 95% of colorectal cancers are CEA positive
• The effects of 124I-M5A on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
• Patients must have at least 2 known sites of metastatic liver disease. Patients should have at least one resectable liver metastasis as assessed by hepatobiliary surgical oncology
• The results of the imaging scans that are performed as part of the standard work up should be available and should have been done within 2 months prior to study entry
• All subjects must have the ability to understand and the willingness to sign a written informed consent
• Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to infusion of radiolabeled antibody