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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 through day 15

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 through day 15

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tumor to background ratio of fluorescence (TBR)

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,457 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial represent a new way of thinking?

"Since 2011, when the first study was sponsored by Amgen, there has been continuous research conducted on Panitumumab-IRDye800. The Phase 2 drug approval followed the initial 75-person study in 2011. 38 studies are currently underway across 16 countries and 151 cities."

Answered by AI

What is the most recent update on Panitumumab-IRDye800's FDA status?

"While there is some data suggesting that Panitumumab-IRDye800 is safe, it only received a score of 2 because this is a Phase 2 trial and thus efficacy has not been demonstrated."

Answered by AI

Are there any vacancies in this clinical trial for new patients?

"The clinical trial mentioned is currently looking for participants. The initial posting was on 4/2/2021 with the latest update being on 12/12/2021 according to clinicaltrials.gov."

Answered by AI

Is Panitumumab-IRDye800 a new medication?

"There are currently 38 clinical trials underway studying Panitumumab-IRDye800. 3 of those live trials are in Phase 3. While the many trials for Panitumumab-IRDye800 are based in Nagoya-shi, Aichi, there are 600 locations running trials for this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Panitumumab-IRDye800 in Head & Neck Cancer

Carissa M Thomas, MD PhD 2021. "Phase II Panitumumab-IRDye800 in Head & Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04511078.