Panitumumab-IRDye800 for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Carissa M. Thomas, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Alabama at Birmingham

Must not be taking: Antiarrhythmics

Disqualifiers: Pregnancy, Breast-feeding, MI, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking certain heart rhythm medications (like quinidine, procanamide, dofetilide, amiodarone, or sotalol), you may not be eligible to participate.

What data supports the effectiveness of the drug Panitumumab-IRDye800 for head and neck cancer?

Research suggests that panitumumab, when used with other treatments like radiotherapy or chemotherapy, may improve outcomes for patients with head and neck cancer by targeting the EGFR pathway, which is often involved in cancer growth. ^{1 2 3 4 5}

Is Panitumumab-IRDye800 safe for use in humans?

In a study with patients having head and neck cancer, Panitumumab-IRDye800 showed minimal side effects, with only one mild (grade 1) adverse event reported and no serious reactions. This suggests it is generally safe for human use. ^{1 2 3 6 7}

How is the drug Panitumumab-IRDye800 different from other treatments for head and neck cancer?

Panitumumab-IRDye800 is unique because it combines a cancer-targeting antibody with a fluorescent dye, allowing surgeons to see cancer cells more clearly during surgery. This fluorescence-guided approach helps in precisely removing cancerous tissue, which is different from standard treatments that do not offer this visual aid. ^{1 2 3 7 8}

Research Team

Carissa M. Thomas, MD, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

Acceptable hematologic status: 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

I am scheduled for surgery to remove my squamous cell carcinoma.

I am 18 years old or older.

Exclusion Criteria

History of infusion reactions to any monoclonal antibody therapies

Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800

I have not had a heart attack, stroke, or uncontrolled heart failure in the last 6 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 50 mg infusion of panitumumab-IRDye800 over 60 minutes

1 day

1 visit (in-person)

Surgical Procedure

Optical imaging is used during surgical procedures to detect head and neck cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Panitumumab-IRDye800 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Panitumumab-IRDye800 Experimental Treatment 1 Intervention

50 mg infusion of panitumumab-IRDye800 given over 60 minutes

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

In a dummy run of the phase III trial involving 23 datasets for head and neck cancer treatment, 87% of gross tumor volumes (GTVs) were deemed acceptable, but only 43.5% of planning target volumes (PTVs) met the required standards, highlighting variability in treatment planning.

The study found significant correlations between the acceptability of treatment contours and the ability to meet dose constraints for organs at risk, indicating that careful planning is crucial for effective and safe radiotherapy in complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality assurance for the EORTC 22071-26071 study: dummy run prospective analysis. Fairchild, A., Langendijk, JA., Nuyts, S., et al.[2019]

In a phase 2 trial involving 152 patients with locally advanced squamous-cell carcinoma of the head and neck, the combination of chemoradiotherapy showed better local-regional control at 2 years (61%) compared to radiotherapy plus panitumumab (51%).

The study found that while both treatment groups experienced significant adverse events, the rates of serious adverse events were similar, suggesting that panitumumab does not provide a sufficient benefit to replace cisplatin in this treatment setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panitumumab plus radiotherapy versus chemoradiotherapy in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-2): a randomised, controlled, open-label phase 2 trial. Giralt, J., Trigo, J., Nuyts, S., et al.[2022]

In a trial involving 46 patients with high-risk, resected head and neck squamous cell carcinoma, the combination of the monoclonal antibody panitumumab with cisplatin chemoradiotherapy showed a promising 2-year progression-free survival rate of 70%.

The treatment was found to be tolerable, with 32% of patients experiencing severe toxicities, indicating that while the regimen is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of post-operative radiotherapy with concurrent cisplatin plus panitumumab in patients with high-risk, resected head and neck cancer. Ferris, RL., Geiger, JL., Trivedi, S., et al.[2020]

In the PRISM trial involving 51 patients with recurrent or metastatic squamous cell carcinoma of the head and neck, panitumumab showed a low overall response rate of only 4%, indicating limited efficacy as a second-line treatment.

The treatment was associated with significant adverse effects, including a high incidence of rash (69%) and one treatment-related death due to angioedema, highlighting safety concerns despite its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRISM: Phase 2 trial with panitumumab monotherapy as second-line treatment in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Rischin, D., Spigel, DR., Adkins, D., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Optimal Dosing Strategy for Fluorescence-Guided Surgery with Panitumumab-IRDye800CW in Head and Neck Cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Phase I dose-finding study of paclitaxel with panitumumab, carboplatin and intensity-modulated radiotherapy in patients with locally advanced squamous cell cancer of the head and neck. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Quality assurance for the EORTC 22071-26071 study: dummy run prospective analysis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Panitumumab plus radiotherapy versus chemoradiotherapy in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-2): a randomised, controlled, open-label phase 2 trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Phase II trial of post-operative radiotherapy with concurrent cisplatin plus panitumumab in patients with high-risk, resected head and neck cancer. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

PRISM: Phase 2 trial with panitumumab monotherapy as second-line treatment in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. [2019]

7. Australia pubmed.ncbi.nlm.nih.gov

Safety of panitumumab-IRDye800CW and cetuximab-IRDye800CW for fluorescence-guided surgical navigation in head and neck cancers. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Chemoradiotherapy with or without panitumumab in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-1): a randomised, controlled, open-label phase 2 trial. [2022]