Clinical Trial · NCT02293954

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

Overview

This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A positron emission tomography (PET) in diagnosing patients with CEA positive cancer. Diagnostic procedures, such as copper Cu 64 anti-CEA monoclonal antibody M5A PET, may help find and diagnose CEA positive cancer that may not be detected by standard diagnostic methods.

Sponsor

City of Hope Medical Center

Phase

N/A

Contacts

Jeffrey Wong (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02293954

Drug / Compound

M5A anti-CEA monoclonal antibody

Isotope(s):

Target(s):

Ligand Class: Antibodies

Eligibility

Inclusion

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
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 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
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
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

Exclusion

Pregnant women are excluded from this study; breastfeeding should be discontinued is the mother is treated with 54Cu-m5A
Patients must not have received prior chemotherapy or radiation for \>= 2 weeks before study enrollment
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 should not have any uncontrolled illness including ongoing or active infection
Any patient who has had exposure to mouse or chimeric (human/mouse) immunoglobulin and has antibody to the M5A