Phase II Panitumumab-IRDye800 in Head & Neck Cancer

Description

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

Study Overview

Study Details

Study overview

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.

Phase II Open-Label Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures

Phase II Panitumumab-IRDye800 in Head & Neck Cancer

Condition
Head and Neck Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
  • 2. 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.
  • 3. Planned standard of care surgery with curative intent for squamous cell carcinoma
  • 4. Male or female patients age ≥ 18 years
  • 5. Have life expectancy of more than 12 weeks
  • 6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
  • 7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
  • 1. Hemoglobin ≥ 9 gm/dL
  • 2. Absolute Neutrophil Count ≥ 1500
  • 3. White Blood Cell count \> 3000/mm3
  • 4. Platelet count ≥ 100,000/mm3
  • 5. Serum creatinine ≤ 1.5 times upper reference range
  • 1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
  • 2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
  • 3. History of infusion reactions to any monoclonal antibody therapies
  • 4. Women who are pregnant or breast-feeding
  • 5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
  • 6. Magnesium or potassium lower than the normal institutional values
  • 7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • 8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • 9. TSH \> 13 micro International Units/mL

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Carissa Thomas, MD PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2027-12-31