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

Not Applicable

Active, not recruiting

Conditions: Gallbladder Cancer
Pancreatic Cancer
Metastatic Cancer
Extrahepatic Bile Duct Cancer
Lung Cancer
Thyroid Gland Medullary Carcinoma
Breast Cancer
Colon Cancer
Gastrointestinal Cancer
Liver and Intrahepatic Biliary Tract Cancer

Interventions: Procedure: radionuclide imaging
Procedure: positron emission tomography
Other: laboratory biomarker analysis
Other: pharmacological study
Drug: Cu 64 anti-CEA monoclonal antibody M5A IV

Registration Number: NCT02293954

Lead Sponsor: City of Hope Medical Center

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)	laboratory biomarker analysis	Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2.
Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)	positron emission tomography	Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2.
Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)	radionuclide imaging	Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2.
Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)	pharmacological study	Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2.
Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)	Cu 64 anti-CEA monoclonal antibody M5A IV	Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2.

Primary Outcome Measures

Name	Time	Method
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 2	At day 2	Tumor uptake measured by SUVmax of 64Cu-DOTA-hT4.66-M5A at day 2 for hottest lesion from each patient. For tumors of at least 2 cm in diameter SUV (=tumor activity concentration/injected activity per unit body weight).
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 1	At day 1	Tumor uptake measured by SUVmax of 64Cu-DOTA-hT4.66-M5A at day1 for hottest lesion from each patient. For tumors of at least 2 cm in diameter SUV (=tumor activity concentration/injected activity per unit body weight).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Human Anti-human Antibody (HAHA) Positive Response to 64Cu Labeled M5A Antibody	At 1 and 3 months post study drug infusion	Approximately 5 ml (1 teaspoon) of blood in a red top tube will be drawn at 1 month post study drug infusion and 3 months post study drug infusion. Response at either 1 or 3 months post study drug infusion constitutes a positive response.
The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to Day 2	At day 1 and day 2	Scan results were compared to known sites of disease as defined by sites identified on CT scans, MRI scans, FDG PET scans, or sites identified at surgery that were histologically positive for cancer. The 64Cu SUVs on both day 1 and 2 scans were evaluated in tumors and selected nontumor organs and tissues (blood pool, liver, spleen, and kidney). Tumor uptake was measured in terms of SUVmax values, while organ uptake to assess biodistribution was measured in terms of SUVmean values. Ratios of tumor-to-blood activity concentration (T:B) were calculated as the ratio of tumor SUVmax to average SUV (SUVmean) measured in the blood pool.