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Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT03405142
Recruitment Status : Not yet recruiting
First Posted : January 19, 2018
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eben Rosenthal, Stanford University

Brief Summary:
This phase II trial studies how well panitumumab-IRDye800 works in identifying head and neck cancer that has spread to the lymph nodes in patients with head and neck cancer. Panitumumab-IRDye800 may help surgeons to identify metastatic lymph nodes during surgical removal of the primary tumor and/or lymph nodes of the neck with equal or better accuracy than the current methods.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Procedure: Computed Tomography Procedure: Lymphoscintigraphy Drug: Panitumumab-IRDye800 Other: Pharmacological Study Procedure: Single Photon Emission Computed Tomography Radiation: Technetium Tc 99m-labeled Tilmanocept Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if near-infrared fluorescence imaging of panitumumab-IRDye800 can identify metastatic disease in regional neck lymph nodes of patients with head and neck squamous cell carcinoma (HNSCC).

SECONDARY OBJECTIVES:

I. Determine if panitumumab-IRDye800 can identify sentinel nodes with the same accuracy as technetium Tc 99m-labeled tilmanocept (Lymphoseek).

OUTLINE:

Beginning 2-5 days before surgery, patients receive panitumumab IRDye800 intravenously (IV) over 60 minutes. On the day before surgery, patients also receive technetium Tc 99m-labeled tilmanocept via injection and undergo lymphoscintigraphy and single photon emission computed tomography/computed tomography (SPECT/CT).

After completion of study, patients are followed up for 30 days.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective) Neck Dissection for Metastatic Lymph Node Identification in Patients With Head and Neck Cancer
Estimated Study Start Date : July 16, 2018
Estimated Primary Completion Date : January 12, 2020
Estimated Study Completion Date : July 13, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Arm Intervention/treatment
Experimental: Diagnostic (panitumumab IRDye800, Lymphoseek)
Beginning 2-5 days before surgery, patients receive panitumumab IRDye800 IV over 60 minutes. On the day before surgery, patients also receive technetium Tc 99m-labeled tilmanocept via injection and undergo lymphoscintigraphy and SPECT/CT.
Procedure: Computed Tomography
Undergo SPECT/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Procedure: Lymphoscintigraphy
Undergo lymphoscintigraphy

Drug: Panitumumab-IRDye800
Given IV
Other Names:
  • Panitumumab IRDye 800
  • RDye800-Panitumumab Conjugate

Other: Pharmacological Study
Correlative studies

Procedure: Single Photon Emission Computed Tomography
Undergo SPECT/CT
Other Names:
  • Medical Imaging, Single Photon Emission Computed Tomography
  • Single Photon Emission Tomography
  • single-photon emission computed tomography
  • SPECT
  • SPECT imaging
  • SPECT SCAN
  • SPET
  • tomography, emission computed, single photon
  • Tomography, Emission-Computed, Single-Photon

Radiation: Technetium Tc 99m-labeled Tilmanocept
Given via injection
Other Names:
  • 99mTc-Diethylenetriamine Pentaacetic Acid-Mannosyl-Dextran
  • 99mTc-DTPA-Mannosyl-Dextran
  • Lymphoseek




Primary Outcome Measures :
  1. Number and location of panitumumab-IRDye800 positive lymph nodes (LNs) that are also tumor- positive at (histo-) pathology [ Time Frame: Up to 30 days ]
    The sensitivity and specificity of the intraoperative findings on whether the LN is fluorescent (i.e. presence of panitumumab-IRDye800) to the histopathological status of the LNs will be calculated. The matched pair Durkalski's test accounting for the cluster-correlation within patient, for all sensitivity and specificity comparisons using the clust.bin.pair package in the R statistical software will be used. Significance for both primary and secondary analyses will be assessed at the 0.05 level and to assess uncertainty, 95% confidence intervals will be provided for all estimates. Descriptive


Secondary Outcome Measures :
  1. The number and location of Lymphoseek positive lymph nodes (LNs) that are also tumor-positive at (histo-) pathology [ Time Frame: Up to 30 days ]
    Whether the LN tracer Lymphoseek can identify metastatic disease in regional neck LNs of patients with head and neck squamous cell cancer will be determined. Similar to the primary analysis, the specificity and sensitivity of Lymphoseek for metastatic LN identification, using histology as the gold standard will be calculated, and compared to neck dissection with Durkalski's test. Since false negatives are of particular concern, the odds of obtaining a false negative using panitumumab-IRDye800 relative to the odds of obtaining a false negative using Lymphoseek-based sentinel node biopsy will be



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
  • Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection, including a (modified) neck dissection
  • Patients with recurrent disease or a new primary will be allowed
  • Planned standard of care surgery with curative intent for squamous cell carcinoma
  • Tumor is accessible for local injection of the sentinel node tracer (for example oral cavity disease)
  • Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1
  • Hemoglobin >= 9 gm/dL
  • White blood cell count > 3000/mm^3
  • Platelet count >= 100,000/mm^3
  • Serum creatinine =< 1.5 times upper reference range

Exclusion Criteria:

  • Received an investigational drug within 30 days prior to first dose of panitumumab IRDye800
  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
  • History of infusion reactions monoclonal antibody therapies
  • Pregnant or breastfeeding
  • Magnesium or potassium lower than the normal institutional values
  • Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Hypersensitivity to dextran and/or modified form thereof

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405142


Locations
United States, California
Stanford University, School of Medicine Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Nick Oberhelman    650-724-3866    noberhel@stanford.edu   
Principal Investigator: Eben L. Rosenthal         
Sponsors and Collaborators
Eben Rosenthal
National Cancer Institute (NCI)
Investigators
Principal Investigator: Eben Rosenthal Stanford Cancer Institute Palo Alto

Responsible Party: Eben Rosenthal, Professor of Otolaryngology, Stanford University
ClinicalTrials.gov Identifier: NCT03405142     History of Changes
Other Study ID Numbers: ENT0065
NCI-2017-02425 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ENT0065 ( Other Identifier: Stanford Cancer Institute Palo Alto )
P30CA124435 ( U.S. NIH Grant/Contract )
R01CA190306 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Antibodies, Monoclonal
Dextrans
Edetic Acid
Diethylenetriamine
Pentetic Acid
Technetium Tc 99m Pentetate
Immunologic Factors
Physiological Effects of Drugs
Anticoagulants
Plasma Substitutes
Blood Substitutes
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Chelating Agents
Sequestering Agents
Iron Chelating Agents
Calcium Chelating Agents
Radiopharmaceuticals