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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-0230 | Other Identifier | Institutional Review Board | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison | |
| NCI-2012-01953 | Registry Identifier | NCI Trial ID |
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Sponsor determined this trial does not support their anticipated clinical development program.
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| Name | Class |
|---|---|
| Cellectar Biosciences, Inc. | INDUSTRY |
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The purpose of this study is to assess the use of investigational compound 124I-NM404 for accurate detection and characterization of a wide variety of solid primary and metastatic malignancies anywhere in the body.
124I-NM404 is a new investigational agent being developed to better identify local tumors and cancerous tumors using imaging technologies such as positron emission tomography (PET) scans. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. 124I-NM404 is only taken up by the cancer cells, not the normal cells. Compared to traditional methods such as CT (computed tomography) or MRI (Magnetic resonance imaging), 124I-NM404 may help physicians more accurately see and evaluate cancerous tumors. This agent has been safely studied in animals and a limited number of human patients with lung cancer. This study is being done to determine the best dose to use and to fully evaluate the images that result from using this new agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple Negative Breast | 124I-NM404 in triple negative breast cancer |
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| Prostate | 124I-NM404 in prostate cancer |
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| Colorectal | 124I-NM404 in colorectal cancer |
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| Gastric | 124I-NM404 in gastric cancer |
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| Ovarian | 124I-NM404 in ovarian cancer |
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| Pancreatic | 124I-NM404 in pancreatic cancer |
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| Esophageal | 124I-NM404 in esophageal cancer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 124I-NM404 | Drug | 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi. |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal Imaging Parameters | To determine the optimal imaging parameters (dose, acquisition time, imaging time post injection, normal organ and tumor dosimetry) of 124I-NM404 in subjects with advanced solid malignancies with one of the following tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number and grade of adverse events attributable to 124I-NM-404 | 2 years |
| PET comparison | compare 18F-FDG PET to 124I-NM404 PET |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be referred to the Phase I oncology research office by their treating oncologist. Outside referrals will be managed by Cancer Connect who will ensure that potential subjects are first evaluated by a UW medical oncologist in the cancer clinic who will then refer them, if appropriate, to the Phase I oncology office.
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Liu, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
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| University of Wisconsin Carbone Cancer Center | View source |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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| Sarcoma | 124I-NM404 in soft tissue sarcoma |
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| Head & Neck | 124I-NM404 in head and neck cancer |
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| 2 years |