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NCT02069080 · ClinicalTrials.gov registry record · Early Phase 1
Imaging CXCR4 Expression in Subjects With Cancer Using 64 Cu-Plerixafor
A Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT02069080 is a Early Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2 participants.
The verdict
NCT02069080, a Early Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
In mouse models and in patients, expression of the chemokine receptor CXCR4 on various cancers has been correlated with aggressive biological behavior, including increased rates and certain sites of metastasis, and decreased survival. Plerixafor (Mozobil ; Genzyme; Cambridge, MA) has been identified as a specific inhibitor of CXCR4, and it is currently approved by the Food and Drug Administration as a stem-cell mobilizing agent in combination with granulocyte colony-stimulating factor in the treatment of non-Hodgkin's lymphoma and multiple myeloma. Our group has recently shown that plerixafor can be labeled with the positron-emitting radionuclide copper-64((64)Cu) to form (64)Cu-plerixafor, which can be used to visualize CXCR4-positive tumor xenografts in mice using small-animal positron emission tomography (PET). Determining CXCR4 expression in tumors using (64)Cu-plerixafor and PET/computerized tomography (CT) scanning could be useful in predicting tumor behavior and responses to current and experimental therapies, including therapies targeting CXCR4, which could lead to more effective personalized cancer treatments. This study s primary objective is to evaluate (64)Cu-plerixafor as an imaging agent for quantifying CXCR4 expression in subjects (greater than or equal to 18 years of age) with cancer; at least 1 detectable solid tumor of greater than or equal to 2 cm in diameter found outside of the lymph nodes, bone marrow, liver, gallbladder, kidney, bladder, and brain; and preexisting biopsies of the tumors obtained since the first detection of the current occurrence/recurrence of disease. The secondary objectives are to correlate (64)Cu-plerixafor standardized uptake value in the target lesion with the level of CXCR4 expression detected via immunohistochemistry and to calculate human dosimetry for (64)Cu-plerixafor. Preexisting tumor biopsies from less than or equal to 75 subjects recruited from the National Cancer Institute and the Georgetown University Hospit
Interventions
- DRUG 64-Cu-plerixafor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-02-20 |
| Est. Completion | 2018-07-10 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02069080
The ClinicalTrials.gov registry entry for NCT02069080 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 64-Cu-plerixafor is the first listed.
NCT02069080 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02069080 about?
NCT02069080 is a clinical study titled "Imaging CXCR4 Expression in Subjects With Cancer Using 64 Cu-Plerixafor". In mouse models and in patients, expression of the chemokine receptor CXCR4 on various cancers has been correlated with aggressive biological behavior, including increased rates and certain sites of metastasis, and decreased survival. Plerixafor (Mozobil ; Genzyme; Cambridge, MA) has been identified...
What is the current status of trial NCT02069080?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2014-02-20. Estimated completion is 2018-07-10.
What interventions are being tested in trial NCT02069080?
The interventions under investigation include: 64-Cu-plerixafor (DRUG).
Who is sponsoring clinical trial NCT02069080?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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