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

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ClinicalTrials.gov Identifier: NCT03405142
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : March 5, 2020
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 Drug: Panitumumab-IRDye800 Drug: Lymphoseek 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: T1 or T2 stage and node negative
T1 or T2 stage primary tumor and node negative (i.e., cN0)
Drug: Panitumumab-IRDye800
50 mg infusion
Other Names:
  • Panitumumab IRDye 800
  • RDye800-Panitumumab Conjugate

Drug: Lymphoseek
2 mCi, infusion
Other Names:
  • 99mTc-Diethylenetriamine Pentaacetic Acid-Mannosyl-Dextran
  • 99mTc-DTPA-Mannosyl-Dextran
  • Technetium Tc 99m-labeled Tilmanocept

Experimental: Any T stage and node positive
Any T stage tumor and node positive (i.e., cN+)
Drug: Panitumumab-IRDye800
50 mg infusion
Other Names:
  • Panitumumab IRDye 800
  • RDye800-Panitumumab Conjugate




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. 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.


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 will be calculated, and compared to neck dissection with Durkalski's test.



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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 with recurrent disease or a new primary will be allowed
  • Planned standard of care surgery with curative intent for squamous cell carcinoma
  • *SNB only cohort: Patients diagnosed with a T1-T2 stage tumor, any subsite within the head and neck that is amenable to local sentinel node tracer injection and are scheduled to undergo surgical resection of the tumor, including a sentinel node biopsy
  • *Neck dissection only cohort: 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
  • Age ≥ 19 years
  • Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
  • Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
  • Hemoglobin ≥ 9 gm/dL
  • White blood cell count > 3000/mm3
  • Platelet count ≥ 100,000/mm3
  • Serum creatinine ≤ 1.5 times upper reference range

    • Only one criterion to be checked for each participant.

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
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United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Grace Yi    650-723-0387    gracesyi@stanford.edu   
Principal Investigator: Fred M Baik         
Sponsors and Collaborators
Eben Rosenthal
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Fred M Baik Stanford Cancer Institute Palo Alto
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Responsible Party: Eben Rosenthal, Professor of Otolaryngology, Stanford University
ClinicalTrials.gov Identifier: NCT03405142    
Other Study ID Numbers: IRB-43013
NCI-2017-02425 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ENT0065 ( Other Identifier: OnCore Number )
P30CA124435 ( U.S. NIH Grant/Contract )
R01CA190306 ( U.S. NIH Grant/Contract )
IRB-43013 ( Other Identifier: stanford-IRB )
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Panitumumab
Diethylenetriamine
Dextrans
Edetic Acid
Pentetic Acid
Antineoplastic Agents, Immunological
Antineoplastic Agents
Anticoagulants
Plasma Substitutes
Blood Substitutes
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Iron Chelating Agents
Calcium Chelating Agents