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

Sponsor

Eben Rosenthal (Other)

Overall Status

Suspended

CT.gov ID

NCT03405142

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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:

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:

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 Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number and location of panitumumab-IRDye800 positive lymph nodes (LNs) that are also tumor- positive at (histo-) pathology [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

The number and location of Lymphoseek positive lymph nodes (LNs) that are also tumor-positive at (histo-) pathology [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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