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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02079 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 14238 | Other Identifier | City of Hope Medical Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET) | Experimental | Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radionuclide imaging | Procedure | Given copper Cu 64 anti-CEA monoclonal antibody M5A IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At day 1 |
| 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). | At day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 1 and 3 months post study drug infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Wong | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36154291 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2018 |
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| positron emission tomography | Procedure | Undergo PET |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| pharmacological study | Other | Correlative studies |
|
|
| Cu 64 anti-CEA monoclonal antibody M5A IV | Drug | Cu 64 anti-CEA monoclonal antibody M5A IV |
|
| 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. | At day 1 and day 2 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Tumor Stage @ Diagnosis | Stage I, Stage II, and Stage III - Cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues. Stage IV - The cancer has spread to distant parts of the body. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Median | Standard Deviation | SUVmax (g/mL) | At day 1 |
|
|
| ||||||||||||||||||||||||||
| 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). | Posted | Mean | Standard Deviation | SUVmax (g/mL) | At day 2 |
|
| |||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | At 1 and 3 months post study drug infusion |
|
| ||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | T:B | At day 1 and day 2 |
|
|
Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 20 | 0 | 20 | 20 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Gastric perforation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Gastrointestinal disorders - Other, spec | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| General disorders and administration sit | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Libido decreased | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Genital edema | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hirsutism | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Skin and subcutaneous tissue disorders - | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 626-218-5265 | pfrankel@coh.org |
| Feb 28, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| D010190 | Pancreatic Neoplasms |
| D012004 | Rectal Neoplasms |
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012002 | Rectal Diseases |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Non-Hispanic White |
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| III |
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| IV |
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| Unknown |
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