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| ID | Type | Description | Link |
|---|---|---|---|
| ENT0050 | Other Identifier | OnCore |
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Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.
This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Safety data from this trial will be studied to assist in the selection of dose levels of panitumumab-IRDye800 for future research. It is hoped that this study will also help in finding better methods for identifying cancer intraoperatively for a more complete surgical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab IRDye 800 | Experimental | Patients will receive Panitumumab IRDye800 prior to their scheduled surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab IRDye 800 | Drug | Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of panitumumab conjugated panitumumab IRDye800 will be measured by assessing number of Grade 2 or higher adverse events | Safety profile of panitumumab conjugated to IRDye800CW (panitumumab IRDye800) will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio | Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio. Fluorescence intensity of tumor tissue compared to that of normal surrounding tissue. | 7 days |
| Optimal timing of the surgical procedure to maximize tumor to background ratio |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Eben L Rosenthal, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| Stanford University, School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33168818 | Derived | Lu G, Nishio N, van den Berg NS, Martin BA, Fakurnejad S, van Keulen S, Colevas AD, Thurber GM, Rosenthal EL. Co-administered antibody improves penetration of antibody-dye conjugate into human cancers with implications for antibody-drug conjugates. Nat Commun. 2020 Nov 9;11(1):5667. doi: 10.1038/s41467-020-19498-y. | |
| 33078373 | Derived |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| da Vinci Firefly | Device | Da Vinci surgical robot with build-in fluorescence imaging option (Firefly technology) |
|
| IMAGE1 + ICG Hopkins telescope and/or VITOM | Device | IMAGE1 + ICG Hopkins telescope and/or VITOM -- Fluorescence camera allowing for imaging of IRDye800. Camera is suitable for open and laparoscopic surgery. |
|
Fluorescence intensity of tissue obtained from patients undergoing surgery at different time points in various cohorts |
| 7 days |
| Stanford |
| California |
| 94305 |
| United States |
| Kapoor S, Lu G, van den Berg NS, Krishnan G, Pei J, Zhou Q, Martin BA, Baik FM, Rosenthal EL, Nishio N. Effect of Formalin Fixation for Near-Infrared Fluorescence Imaging with an Antibody-Dye Conjugate in Head and Neck Cancer Patients. Mol Imaging Biol. 2021 Apr;23(2):270-276. doi: 10.1007/s11307-020-01553-1. Epub 2020 Oct 19. |
| 31421471 | Derived | Fakurnejad S, van Keulen S, Nishio N, Engelen M, van den Berg NS, Lu G, Birkeland A, Baik F, Colevas AD, Rosenthal EL, Martin BA. Fluorescence molecular imaging for identification of high-grade dysplasia in patients with head and neck cancer. Oral Oncol. 2019 Oct;97:50-55. doi: 10.1016/j.oraloncology.2019.08.008. Epub 2019 Aug 12. |