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Panitumumab-IRDye800 for Head and Neck Cancer

Phase 2
Recruiting
Led By Jason Warram, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned standard of care surgery with curative intent for squamous cell carcinoma
Male or female patients age ≥ 18 years
Must not have
Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Women who are pregnant or breast-feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 through day 15
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if panitumumab-IRDye800 can help doctors better see and treat cancer, and if it is safe to use.

Who is the study for?
This trial is for adults over 18 with a specific type of cancer in the head and neck area, who are scheduled for surgery. They must have normal kidney, liver, blood counts, and not be on certain heart rhythm drugs or have had recent severe heart issues. Pregnant women or those with some lung conditions can't join.
What is being tested?
The study tests Panitumumab-IRDye800's ability to highlight cancer cells during surgery compared to normal tissue. It aims to confirm how safe this drug is when used in patients undergoing surgical resection for squamous cell carcinoma.
What are the potential side effects?
Potential side effects include reactions similar to other monoclonal antibody therapies such as allergic reactions during infusion and possibly changes in blood levels of minerals like magnesium or potassium.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery to remove my squamous cell carcinoma.
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I am 18 years old or older.
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I can care for myself but cannot do heavy physical work.
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I have been diagnosed with squamous cell carcinoma in my head or neck.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication for heart rhythm problems.
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I am not pregnant or breast-feeding.
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I have had interstitial pneumonitis or pulmonary fibrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 through day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 through day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor to background ratio of fluorescence (TBR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Panitumumab-IRDye800Experimental Treatment1 Intervention
50 mg infusion of panitumumab-IRDye800 given over 60 minutes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab-IRDye800
2019
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,359 Total Patients Enrolled
Jason Warram, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Carissa Thomas, MD PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Panitumumab-IRDye800 Clinical Trial Eligibility Overview. Trial Name: NCT04511078 — Phase 2
Head and Neck Cancers Research Study Groups: Panitumumab-IRDye800
Head and Neck Cancers Clinical Trial 2023: Panitumumab-IRDye800 Highlights & Side Effects. Trial Name: NCT04511078 — Phase 2
Panitumumab-IRDye800 2023 Treatment Timeline for Medical Study. Trial Name: NCT04511078 — Phase 2
~9 spots leftby Dec 2026
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