Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
NCT ID: NCT02293954
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2015-11-11
2026-08-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)
Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2.
radionuclide imaging
Given copper Cu 64 anti-CEA monoclonal antibody M5A IV
positron emission tomography
Undergo PET
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Cu 64 anti-CEA monoclonal antibody M5A IV
Cu 64 anti-CEA monoclonal antibody M5A IV
Interventions
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radionuclide imaging
Given copper Cu 64 anti-CEA monoclonal antibody M5A IV
positron emission tomography
Undergo PET
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Cu 64 anti-CEA monoclonal antibody M5A IV
Cu 64 anti-CEA monoclonal antibody M5A IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Wong
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2014-02079
Identifier Type: REGISTRY
Identifier Source: secondary_id
14238
Identifier Type: OTHER
Identifier Source: secondary_id
14238
Identifier Type: -
Identifier Source: org_study_id