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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02293954
Collaborator
National Cancer Institute (NCI) (NIH)
20
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: radionuclide imaging
  • Procedure: positron emission tomography
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
  • Drug: Cu 64 anti-CEA monoclonal antibody M5A IV
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. To characterize the frequency of titer of the human anti-human antibody (HAHA) response to 64Cu labeled M5A antibody.

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pilot Study: Detection of Carcinomas Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA)
Actual Study Start Date :
Nov 11, 2015
Anticipated Primary Completion Date :
Sep 11, 2022
Anticipated Study Completion Date :
Sep 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: radionuclide imaging
Given copper Cu 64 anti-CEA monoclonal antibody M5A IV
Other Names:
  • radionuclide scanning
  • Procedure: positron emission tomography
    Undergo PET
    Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
  • Other: laboratory biomarker analysis
    Correlative studies

    Other: pharmacological study
    Correlative studies
    Other Names:
  • pharmacological studies
  • Drug: Cu 64 anti-CEA monoclonal antibody M5A IV
    Cu 64 anti-CEA monoclonal antibody M5A IV

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of each modality in locating cancer in each of four regions (primary, hepatic, extra-hepatic abdominal, and extra-abdominal) using lesion analysis [Up to day 2]

      For lesion analysis, the efficacy of each modality will be evaluated where a successful outcome will be defined as the ability of at least one known tumor identified by conventional imaging modalities to be imaged using the M5A antibody. Using the standard statistical formulas, the number of true positives, false positives, true negatives, and false negatives, as well as the sensitivity and corresponding 95% confidence interval will be estimated using the method of Lee and Dubin or Rao and Scott, which accounts for the correlation between lesions within in same subject.

    2. Efficacy of each modality in locating cancer in each of four regions (primary, hepatic, extra-hepatic abdominal, and extra-abdominal) using region analysis [Up to day 2]

      For region analysis, a successful outcome will be defined as the identification of suspicious tissue within a region. Using the standard statistical formulas, the number of true positives, false positives, true negatives, and false negatives, as well as the sensitivity and corresponding 95% confidence interval will be estimated using the method of Lee and Dubin or Rao and Scott, which accounts for the correlation between lesions within in same subject.

    3. Pharmacokinetic parameters of copper Cu 64 anti-CEA monoclonal antibody M5A [Pre-dose, 30 minutes, and 1, 2, and 3-4 hours post start of infusion]

      Blood samples will be drawn at various time points to construct the blood activity curve. Urine data will also be included in our analyses to check the whole body clearance curves. A computer pharmacokinetic model containing 5 compartments including blood, liver, residual body, urine and feces will be used to analyze time activity data. Residence times for various organs will be calculated from this pharmacokinetic model and/or uptake data. Different residence times for different isotopes, e.g. 64Cu, will be calculated by adjusting for physical decay. These times are then substituted into the OLINDA program.

    4. Immunogenicity properties of copper Cu 64 anti-CEA monoclonal antibody M5A [Up to 3 months]

      The patient's serum samples are evaluated in both a bridging radioimmunoassay and an HPLC assay. The sera are incubated with the appropriate radiolabeled M5A and then analyzed by HPLC size exclusion chromatography on a Superose 6 HR column.

    Secondary Outcome Measures

    1. Incidence of adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [Up to 3 months]

      Safety data will be displayed and abnormal laboratory values flagged. The frequency of adverse events will be tabulated by body system.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jeffrey Wong, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT02293954
    Other Study ID Numbers:
    • 14238
    • NCI-2014-02079
    • 14238
    First Posted:
    Nov 19, 2014
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022

    Study Results

    No Results Posted as of Aug 24, 2022