Clinical trial NCT02293954: Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Official title: Pilot Study: Detection of Carcinomas Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Colon Cancer
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Gastrointestinal Cancer
Liver and Intrahepatic Biliary Tract Cancer
Lung Cancer
Metastatic Cancer
Pancreatic Cancer
Rectal Cancer
Thyroid Gland Medullary Carcinoma
Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 1
timeFrame: At day 1
measure: Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 2
timeFrame: At day 2
Secondary outcomes:
measure: Number of Participants With Human Anti-human Antibody (HAHA) Positive Response to 64Cu Labeled M5A Antibody
timeFrame: At 1 and 3 months post study drug infusion
measure: The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to Day 2
timeFrame: At day 1 and day 2
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jeffrey Wong
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong JYC, Yamauchi DM, Adhikarla V, Simpson J, Frankel PH, Fong Y, Melstrom KA, Chen YJ, Salehian BD, Woo Y, Dandapani SV, Colcher DM, Poku EK, Yazaki PJ, Wu AM, Shively JE. First-In-Human Pilot PET Immunoimaging Study of 64Cu-Anti-Carcinoembryonic Antigen Monoclonal Antibody (hT84.66-M5A) in Patients with Carcinoembryonic Antigen-Producing Cancers. Cancer Biother Radiopharm. 2023 Feb;38(1):26-37. doi: 10.1089/cbr.2022.0028. Epub 2022 Sep 26.