Cetuximab IRDye800 Study as an Optical Imaging Agent to Detect Cancer During Surgical Procedures

NCT01987375 | Terminated Phase 1 DMC

• 2 other identifiers: IRB-35068ENT0049
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open label, single institution, Phase 1 dose-escalation study to determine the safety profile of cetuximab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Participants will be given a dose of an approved head and neck cancer drug (Cetuximab) along with an investigational study drug called Cetuximab-IRDye800. Cetuximab-IRDye800 is a drug that is given prior to surgery that attaches to cancer cells and appears to make them visible to the doctor when he uses a special camera during the operation. The investigators are evaluating whether or not the use of the study drug along with the special camera will better identify the cancer while patients are in the operating room.

Conditions

Head and Neck Cancer

Keywords

HNSCC; Imaging

Outcome Measures

Primary Outcomes (1)

• Number of subjects in a cohort experiencing a DLT (gr 2 or greater AE considered at least possibly related to study drug & clinically significant by the PI) after receiving cetuximab conjugated to the optical dye IRDye800CW(cetuximab-IRDye800)

  30 days post intervention

Secondary Outcomes (1)

• Number of subjects with identifiable cancer as compared to surrounding normal tissue by correlating fluorescence with histological evidence of tumor post receipt of cetuximab conjugated to the optical dye, IRDye800CW (cetuximab-IRDye800)

  One year post intervention

Study Arms (1)

Cetuximab-IRDye800 Participants

EXPERIMENTAL

Participants who received the study drug cetuximab-IRDye800, following a loading dose of unlabeled cetuximab

Drug: Cetuximab-IRDye800

Interventions

Cetuximab-IRDye800 DRUG

a single dose of the study drug following a single loading dose of unlabeled cetuximab

Cetuximab-IRDye800 Participants

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 diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
• Planned standard of care surgery with curative intent for squamous cell carcinoma
• Age ≥ 19 years
• Have life expectancy of more than 12 weeks
• 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 ≥ 9gm/dL
• Platelet count ≥ 100,000/mm3
• Magnesium, potassium and calcium greater than or equal than the lower limit of normal range per institution normal lab values
• TSH \<10 micro International Units/mL

You may not qualify if:

• Received an investigational drug within 30 days prior to first dose of cetuximab-IRDye800
• Had within 6 months prior to enrollment: MI, CVA, uncontrolled CHF, significant liver disease, unstable angina
• Inadequately controlled hypertension with or without current antihypertensive medications
• History of infusion reactions to cetuximab or other monoclonal antibody therapies.
• Women who are pregnant or breast feeding
• Patients who have a grade 2 or greater reaction with the test/loading cetuximab dose.
• Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females).
• Lab values that in the opinion of the primary surgeon would prevent surgical resection.
• Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
• Patients with TSH\>11

Sponsors & Collaborators

• Eben Rosenthal: lead

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Eben Rosenthal, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: November 19, 2013
• Study Start: November 1, 2015
• Primary Completion: April 19, 2017
• Study Completion: April 19, 2017
• Last Updated: June 24, 2019

Record last verified: 2019-06

Locations

US (1)