RECRUITING

Phase II Panitumumab-IRDye800 in Head & Neck Cancer

Conditions

Head and Neck Cancer panitumumab optical imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2021-04-02

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04511078

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Norma Miller, RN

CONTACT

(205) 975-6169

ncmiller@uabmc.edu

Principal Investigator

Carissa Thomas, MD PhD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-02

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2021-04-02

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

panitumumab
optical imaging

Additional Relevant MeSH Terms

Head and Neck Cancer