Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer

Inclusion Criteria:

• Patients must have histologically confirmed primary or metastatic cancer; ifbiopsies were performed at an outside facility, the histology must be reviewed andconfirmed by the Department of Pathology at the City of Hope

• Patients must have tumors that produce CEA as documented by a current or pasthistory of an elevated serum CEA above the institutional limit of normal, or byimmunohistochemical methods; NOTE: Patients with colorectal cancer are exempt fromthis requirement since > 95% are CEA positive

• 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 andfor six months following duration of study participation; should a woman becomepregnant or suspect that she is pregnant while participating on the trial, sheshould inform her treating physician immediately

• Patients must have a known site of disease; please note, for patients undergoingneoadjuvant therapy, this requirement must be met retrospectively prior to the startof neoadjuvant therapy; patients who are in radiological/clinical remission afterneoadjuvant therapy, prior to infusion of radiolabeled antibody, are still eligible

• Although not mandated by the protocol, the results of the CT scan and labs (completeblood count [CBC], comprehensive metabolic panel [CMP]) that are performed as partof the standard work up should be available and should have been done within 2months prior to study entry

• All subjects must have the ability to understand and the willingness to sign awritten informed consent

• Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to infusion of radiolabeled antibody

Exclusion Criteria:

• Patients should not have any uncontrolled illness including ongoing or activeinfection

• History of allergic reactions attributed to compounds of similar chemical orbiologic composition to copper Cu 64 anti-CEA monoclonal antibody M5A (64Cu-M5A)

• Patients must not have received prior chemotherapy or radiation for >= 2 weeksbefore study enrollment

• Pregnant women are excluded from this study; breastfeeding should be discontinued isthe mother is treated with 54Cu-m5A

• Any patient who has had exposure to mouse or chimeric (human/mouse) immunoglobulinand has antibody to the M5A

• Subjects, who in the opinion of the investigator, may not be able to comply with thesafety monitoring requirements of the study