Panitumumab-IRDye800 for Head and Neck Cancer

Overseen By Destiny Talley, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Must not be taking: Antiarrhythmics

Disqualifiers: Pregnancy, Breast-feeding, MI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the drug panitumumab-IRDye800 can effectively highlight head and neck cancer cells during surgery, making them easier to distinguish from normal tissue. The study will also assess the drug's safety for patients. Individuals diagnosed with squamous cell carcinoma in the head or neck and planning surgery to remove the cancer might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that panitumumab-IRDye800 is likely to be safe for humans?

Research has shown that panitumumab-IRDye800 is generally safe for people. In an earlier study, only 7.4% of participants experienced side effects, similar to those from the original drug, panitumumab, already used for other health issues. This indicates that the treatment is usually well-tolerated. These safety findings are based on current research, and the ongoing trial will continue to monitor and confirm these results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for head and neck cancer?

Panitumumab-IRDye800 is unique because it combines an anti-cancer antibody with a fluorescent dye, which helps surgeons see cancerous tissue more clearly during surgery. Unlike traditional treatments for head and neck cancer that primarily focus on removing or shrinking tumors through surgery, radiation, or chemotherapy, this approach enhances surgical precision by illuminating cancer cells. Researchers are excited about this treatment because it has the potential to improve surgical outcomes by ensuring more complete tumor removal, which could lead to better recovery and lower recurrence rates for patients.

What evidence suggests that panitumumab-IRDye800 is effective for identifying head and neck cancer?

Research has shown that Panitumumab-IRDye800, the treatment under study in this trial, holds promise for detecting head and neck cancer. In earlier studies, it enabled doctors to distinguish cancer from normal tissue more clearly, enhancing surgical precision. One study found that patients experienced very few side effects, with only one mild case reported. Panitumumab, the primary drug, is already approved for other uses, which boosts confidence in its safety. ^{2 3 6 7 8}

Who Is on the Research Team?

Anthony Morlandt, DDS MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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

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

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 for my head or neck cancer, including if it's a recurrence or a new primary cancer.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Panitumumab-IRDye800

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

The study demonstrated that the fluorescently labeled antibodies cetuximab-IRDye800CW and panitumumab-IRDye800CW are safe for use in surgical imaging, with minimal toxicities observed in 27 patients with head and neck squamous cell carcinoma.

Both antibodies showed similar pharmacodynamic properties, and no significant safety concerns were raised, indicating potential for other therapeutic antibodies to be repurposed for imaging with limited preclinical data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of panitumumab-IRDye800CW and cetuximab-IRDye800CW for fluorescence-guided surgical navigation in head and neck cancers. Gao, RW., Teraphongphom, N., de Boer, E., et al.[2019]

In a study involving 24 patients with head and neck squamous cell carcinoma, a fixed dose of 50 mg of the fluorescently labeled antibody panitumumab-IRDye800CW was identified as the optimal dose for enhancing fluorescence during surgery.

The study found that reducing the time between infusion and surgery to within 2 days significantly increased the fluorescence intensity of the tumors, suggesting that timing is crucial for effective imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Dosing Strategy for Fluorescence-Guided Surgery with Panitumumab-IRDye800CW in Head and Neck Cancer. Nishio, N., van den Berg, NS., van Keulen, S., et al.[2021]

In a phase 2 trial involving 150 patients with locally advanced squamous-cell carcinoma of the head and neck, the addition of panitumumab to chemoradiotherapy did not improve local-regional control compared to chemoradiotherapy alone, with control rates of 61% versus 68%, respectively.

Patients receiving panitumumab experienced higher rates of severe side effects, such as dysphagia and mucosal inflammation, indicating that the combination treatment may not be safer or more effective than standard therapy.

NCBI (Pubmed)

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. Mesía, R., Henke, M., Fortin, A., et al.[2022]

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 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 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]

In a phase I study involving 19 patients with advanced squamous cell carcinoma of the head and neck, the combination of panitumumab, carboplatin, and escalating doses of paclitaxel with intensity-modulated radiotherapy (IMRT) showed a high overall complete clinical response rate of 95%.

The treatment was generally well tolerated, with the maximum tolerated dose of paclitaxel identified at 30 mg/m², although all patients experienced significant side effects like mucositis and oral pain, indicating the need for careful management of these toxicities.

NCBI (Pubmed)

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. Wirth, LJ., Allen, AM., Posner, MR., et al.[2020]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04511078

Phase II Panitumumab-IRDye800 in Head & Neck Cancer The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3595117/

Use of Panitumumab-IRDye800 to Image Microscopic ... Panitumumab-IRDye800 may have clinical utility in detection and removal of microscopic HNSCC using existing intraoperative optical imaging hardware.

3. aacrjournals.org aacrjournals.org/clincancerres/article/30/18/4016/747459/Interim-Phase-II-Results-Using-Panitumumab

Interim Phase II Results Using Panitumumab-IRDye800CW ... Interim Phase II results using Panitumumab-IRDye800CW during transoral robotic surgery in patients with oropharyngeal cancer.

4. withpower.com withpower.com/trial/phase-3-head-and-neck-neoplasms-3-2021-51008

Panitumumab-IRDye800 for Head and Neck Cancer 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 ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06819228/window-trial-of-fluorescently-labeled-panitumumab-panitumumab-irdye800-in-head-and-neck-cancer

Window Trial of Fluorescently Labeled Panitumumab ... This study is exploring the use of Panitumumab in Head and Neck Cancer. Panitumumab is an approved drug named Vectibix and is used as an ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29721094/

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

7. thno.org thno.org/v08p2488.htm

Safety of panitumumab-IRDye800CW and cetuximab- ... Conclusions: Panitumumab-IRDye800CW and cetuximab-IRDye800CW have toxicity and pharmacodynamic profiles that match the parent compound, suggesting that other ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32880818/

Safety and Stability of Antibody-Dye Conjugate in Optical ... Conclusions: Panitumumab-IRDye800CW was safe and stable to administer over a 54-month window with a low rate of adverse events (7.4 %) which is ...