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

NCT03405142 | Completed Phase 2 Results DMC FDA Drug

• 5 other identifiers: IRB-43013NCI-2017-02425ENT0065P30CA124435R01CA190306
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 2 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.

Conditions

Head and Neck Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Head and Neck (SCCHN); Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Detection of Malignancy in Excised Lymph Nodes by Pathology or Labeling With Lymphoseek and/or Panitumumab-IRDye800

  After administration of panitumumab-IRDye800 alone or with Lymphoseek, lymph nodes potentially containing malignant tumor cells were surgically removed, and the lymph node tissue was evaluated for panitumumab-IRDye800 fluorescence intensity. For each subject, the 5 lymph nodes with the strongest fluorescence signal were tabulated against the Lymphoseek and histopathologic findings for those specific lymph nodes. For each of the 3 modalities, a positive finding is considered indicative of malignancy. The outcome is reported as the number of positive findings by modality for each cohort. The outcome is a number without dispersion.

  Up to 30 days

Study Arms (2)

T1 or T2 stage and node-negative

EXPERIMENTAL

T1 or T2 stage primary tumor and node-negative (ie, cN0)

Drug: Panitumumab-IRDye800; Drug: Lymphoseek

Any T stage and node-positive

EXPERIMENTAL

Any T stage tumor and node-positive (ie, cN+)

Drug: Panitumumab-IRDye800

Interventions

Panitumumab-IRDye800 DRUG

Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy). Panitumumab dose is \< 1/12 of the therapeutic dose.

Also known as: Panitumumab IRDye 800, RDye800-Panitumumab Conjugate

Any T stage and node-positive; T1 or T2 stage and node-negative

Lymphoseek DRUG

Local, peri-tomoral injection with 2 mCi Lymphoseek (99mTc Tilmanocept) (as 4 x 0.1 mL injections of Lymphoseek solution

Also known as: 99mTc-Diethylenetriamine Pentaacetic Acid-Mannosyl-Dextran, 99mTc-DTPA-Mannosyl-Dextran, Technetium Tc 99m-labeled Tilmanocept

T1 or T2 stage and node-negative

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Cohort 1: T1-T2 stage tumor diagnosis, any subsite within the head and neck that is amenable to local sentinel node tracer injection, and scheduled to undergo surgical resection of the tumor, including a sentinel node biopsy
• Cohort 2 (neck dissection only): Diagnosis 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

You may not qualify if:

• 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
• Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
• History or evidence of interstitial pneumonitis or pulmonary fibrosis
• Hypersensitivity to dextran and/or modified forms

Sponsors & Collaborators

• Eben Rosenthal: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Roan Courtney Raymundo
• Organization: Stanford Medicine at Stanford University

rcraymun@stanford.edu

650-721-4071

Study Officials

• Fred M Baik

  Stanford Cancer Institute Palo Alto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: August 1, 2019
• Primary Completion: December 4, 2019
• Study Completion: April 27, 2021
• Last Updated: November 10, 2022
• Results First Posted: November 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)