Phase II Panitumumab-IRDye800 in Head & Neck Cancer

NCT04511078 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: IRB-300005079UAB 1969
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and the further characterize the safety profile of this drug.

Conditions

Head and Neck Cancer

Keywords

panitumumab; optical imaging

Outcome Measures

Primary Outcomes (1)

• Tumor to background ratio of fluorescence (TBR)

  fluorescence intensity of tumor tissue compared to that of normal surrounding tissue

  Day 0 through Day 15

Study Arms (1)

Panitumumab-IRDye800

EXPERIMENTAL

50 mg infusion of panitumumab-IRDye800 given over 60 minutes

Drug: Panitumumab-IRDye800

Interventions

Panitumumab-IRDye800 DRUG

single dose infusion of panitumumab-IRDye800CW

Also known as: panitumumab-IRDye800CW

Panitumumab-IRDye800

Eligibility Criteria

• Age: 18 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
• Diagnosis of 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
• Male or female patients age ≥ 18 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 ≥ 9 gm/dL
• Absolute Neutrophil Count ≥ 1500
• 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
• Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
• History of infusion reactions to any monoclonal antibody therapies
• Women who are pregnant or breast-feeding
• Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
• Magnesium or potassium lower than the normal institutional values
• Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
• Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
• TSH \> 13 micro International Units/mL

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Anthony Morlandt, DDS MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Destiny Talley, RN

CONTACT

(205) 975-6169; destinytaylor@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: April 2, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)