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

PRIMARY OBJECTIVES:

I. To determine the ability of 64Cu labeled M5A antibody (copper Cu 64 anti-CEA monoclonal
antibody M5A) to localize CEA positive cancers (such as gastrointestinal, lung, medullary
thyroid and breast cancers), as determined by PET imaging.

SECONDARY OBJECTIVES:

I. To characterize the frequency of titer of the human anti-human antibody (HAHA) response to
64Cu labeled M5A antibody.

II. To determine the safety of administration of 64Cu labeled M5A antibody.

OUTLINE:

Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A intravenously (IV) on day 0
and then undergo PET on day 1 and day 2.

After completion of study, patients are followed up at 1 and 3 months.

Inclusion Criteria:

- Patients must have histologically confirmed primary or metastatic cancer; if biopsies
were performed at an outside facility, the histology must be reviewed and confirmed by
the Department of Pathology at the City of Hope

- Patients must have tumors that produce CEA as documented by a current or past history
of an elevated serum CEA above the institutional limit of normal, or by
immunohistochemical methods; NOTE: Patients with colorectal cancer are exempt from
this 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 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 a known site of disease; please note, for patients undergoing
neoadjuvant therapy, this requirement must be met retrospectively prior to the start
of neoadjuvant therapy; patients who are in radiological/clinical remission after
neoadjuvant therapy, prior to infusion of radiolabeled antibody, are still eligible

- Although not mandated by the protocol, the results of the CT scan and labs (complete
blood count [CBC], comprehensive metabolic panel [CMP]) 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

Exclusion Criteria:

- Patients should not have any uncontrolled illness including ongoing or active
infection

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

- Patients must not have received prior chemotherapy or radiation for >= 2 weeks before
study enrollment

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

- Any patient who has had exposure to mouse or chimeric (human/mouse) immunoglobulin and
has antibody to the M5A

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