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
Conditions
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.
Interventions
PROCEDUREradionuclide imaging
Given copper Cu 64 anti-CEA monoclonal antibody M5A IV
PROCEDUREpositron emission tomography
Undergo PET
OTHERlaboratory biomarker analysis
Correlative studies
OTHERpharmacological study
Correlative studies
DRUGCu 64 anti-CEA monoclonal antibody M5A IV
Cu 64 anti-CEA monoclonal antibody M5A IV
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) Patients receive 15 mCi/5 mg 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
Cu 64 anti-CEA monoclonal antibody M5A IV: Cu 64 anti-CEA monoclonal antibody M5A IV | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) |
|---|---|
| Age, Continuous | 57 years |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 10 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 14 Participants |
| Tumor Stage @ Diagnosis I | 1 Participants |
| Tumor Stage @ Diagnosis II | 1 Participants |
| Tumor Stage @ Diagnosis III | 5 Participants |
| Tumor Stage @ Diagnosis IV | 11 Participants |
| Tumor Stage @ Diagnosis Unknown | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A 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).
Time frame: At day 1
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) | Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 1 | 22.0 SUVmax (g/mL) | Standard Deviation 16.9 |
Primary
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A 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).
Time frame: At day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) | Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 2 | 30.7 SUVmax (g/mL) | Standard Deviation 24.4 |
Secondary
Number of Participants With Human Anti-human Antibody (HAHA) Positive Response to 64Cu Labeled M5A Antibody
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.
Time frame: At 1 and 3 months post study drug infusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) | Number of Participants With Human Anti-human Antibody (HAHA) Positive Response to 64Cu Labeled M5A Antibody | 1 Participants |
Secondary
The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to 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.
Time frame: At day 1 and day 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) | The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to Day 2 | Day 2 | 6.5 T:B | Standard Deviation 4.9 |
| Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) | The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to Day 2 | Day 1 | 3.3 T:B | Standard Deviation 2.7 |