Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
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|ClinicalTrials.gov Identifier: NCT02293954|
Recruitment Status : Active, not recruiting
First Posted : November 19, 2014
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Procedure: radionuclide imaging Procedure: positron emission tomography Other: laboratory biomarker analysis Other: pharmacological study Drug: Cu 64 anti-CEA monoclonal antibody M5A IV||Not Applicable|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study: Detection of Carcinomas Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA)|
|Actual Study Start Date :||November 11, 2015|
|Estimated Primary Completion Date :||June 11, 2021|
|Estimated Study Completion Date :||June 11, 2021|
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 Name: radionuclide scanning
Procedure: positron emission tomography
Other: laboratory biomarker analysis
Other: pharmacological study
Other Name: pharmacological studies
Drug: Cu 64 anti-CEA monoclonal antibody M5A IV
Cu 64 anti-CEA monoclonal antibody M5A IV
- Efficacy of each modality in locating cancer in each of four regions (primary, hepatic, extra-hepatic abdominal, and extra-abdominal) using lesion analysis [ Time Frame: 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.
- Efficacy of each modality in locating cancer in each of four regions (primary, hepatic, extra-hepatic abdominal, and extra-abdominal) using region analysis [ Time Frame: 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.
- Pharmacokinetic parameters of copper Cu 64 anti-CEA monoclonal antibody M5A [ Time Frame: 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.
- Immunogenicity properties of copper Cu 64 anti-CEA monoclonal antibody M5A [ Time Frame: 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.
- Incidence of adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293954
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Jeffrey Wong||City of Hope Medical Center|