[89Zr]Panitumumab Imaging for Head and Neck Cancer

Overseen by Suzanne Lapi, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Alabama at Birmingham

Must not be taking: Antiarrhythmics

Disqualifiers: Pregnancy, Severe renal disease, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a new imaging method using a special radioactive substance to better locate and measure head and neck tumors in patients. It aims to provide clearer images than the current standard method. The study involves injecting a small amount of a drug to help the radioactive substance attach to the tumor cells, making them more visible on scans.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug [89Zr]Panitumumab Tracer for head and neck cancer?

Research shows that panitumumab, a component of the drug, has been used effectively in combination with other treatments for head and neck cancer, improving outcomes in some cases. Additionally, zirconium-89, used in similar imaging studies, has shown promise in detecting cancer spread, which can help guide treatment decisions. ^{1 2 3 4 5}

Is [89Zr]Panitumumab safe for use in humans?

Panitumumab, also known as Vectibix, is a human antibody approved for treating certain types of cancer, and studies have shown it has limited systemic toxicity, meaning it generally doesn't cause widespread harm in the body. However, specific safety data for [89Zr]Panitumumab in humans is not detailed in the available research. ^{1 4 6 7 8}

How is [89Zr]Panitumumab Imaging different from other treatments for head and neck cancer?

[89Zr]Panitumumab Imaging is unique because it combines a monoclonal antibody, panitumumab, with a radioactive element, zirconium-89, to create a PET imaging probe. This allows for non-invasive imaging of tumors that express the HER1 receptor, providing detailed information about the cancer's location and potentially guiding targeted therapy. ^{1 3 4 6 9}

Research Team

Suzanne Lapi, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed head and neck squamous cell carcinoma, scheduled for surgery. Participants must have normal organ function tests, no history of severe heart or liver conditions within the past 6 months, not be pregnant or breastfeeding, and cannot exceed a weight limit due to scanner size.

Inclusion Criteria

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

I am older than 18 years.

I am scheduled for surgery for my newly diagnosed head or neck cancer.

Exclusion Criteria

Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).

Magnesium (<1.7 mg/dL) or potassium (<3.6 mmol/L) lower than the normal institutional values

Weight over 350 lbs., due to the scanner bore size

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (phone call)

Imaging Preparation

Participants receive a standard of care FDG-PET/MRI, vital signs check, and infusion of panitumumab followed by injection of [89Zr]Panitumumab

1 day

1 visit (in-person)

Imaging

Participants undergo [89Zr]panitumumab-PET/MRI imaging 2 to 4 days after receiving the radiopharmaceutical

2-4 days

1 visit (in-person)

Surgical Resection and Follow-up

Patients undergo standard of care surgical resection and follow-up review of medical records for histological assessments

5-9 days

Treatment Details

Interventions

• [89Zr]Panitumumab Tracer (Monoclonal Antibodies)

Trial Overview [89Zr]Panitumumab PET/MRI imaging is being tested against standard [18F-FDG] PET/MRI to see if it's better at finding the exact size and location of tumors in patients with head and neck cancer. This study will not affect treatment plans as it's only for imaging purposes.

Participant Groups

Group I: [89Zr]panitumumab-PET/MRI patients Experimental Treatment 1 Intervention

All study patients will receive \[89Zr\]Panitumumab-PET/MRI imaging.

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

Panitumumab is a human monoclonal antibody that targets the epidermal growth factor receptor (EGFR), which plays a crucial role in the growth and spread of cancer cells, specifically in metastatic colorectal carcinoma.

It is used as a single-agent treatment for patients whose cancer has progressed after standard chemotherapy regimens, including fluoropyrimidine, oxaliplatin, and irinotecan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panitumumab (vectibix). Gemmete, JJ., Mukherji, SK.[2021]

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 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]

Immuno-PET using (89)Zr-labeled cmAb U36 demonstrated a sensitivity of 72% for detecting lymph node metastases in head and neck squamous cell carcinoma patients, outperforming conventional imaging methods like CT/MRI in certain aspects.

The accuracy of immuno-PET was 93% for detecting operated lymph node levels, indicating its potential as a reliable diagnostic tool for guiding treatment decisions in patients at high risk for metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of immuno-positron emission tomography with zirconium-89-labeled chimeric monoclonal antibody U36 in the detection of lymph node metastases in head and neck cancer patients. Börjesson, PK., Jauw, YW., Boellaard, R., et al.[2015]

(89)Zr-DFO-panitumumab can be produced with high radiochemical purity and specific activity, allowing for effective imaging of HER1 expression in tumors, particularly in breast cancer models with varying HER1 levels.

Immuno-PET imaging demonstrated a strong correlation between HER1 expression and tumor uptake of (89)Zr-DFO-panitumumab, suggesting its potential as a clinically feasible tool for targeting and visualizing HER1-expressing tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zirconium-89 labeled panitumumab: a potential immuno-PET probe for HER1-expressing carcinomas. Bhattacharyya, S., Kurdziel, K., Wei, L., et al.[2022]

The study involved 14 adult patients with head and neck squamous cell carcinoma (HNSCC) and demonstrated that the tumor-targeted radiotracer 89Zr-pan PET/CT significantly improved diagnostic specificity to 96.3%, compared to 74.1% for 18F-FDG PET/CT alone.

89Zr-pan PET/CT was found to be safe, with only one minor adverse event reported, and it effectively helped differentiate between incidental findings and true cancerous lesions, enhancing the localization of metastatic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

89Zr-panitumumab Combined With 18F-FDG PET Improves Detection and Staging of Head and Neck Squamous Cell Carcinoma. Lee, YJ., van den Berg, NS., Duan, H., et al.[2023]

Panitumumab, a fully human monoclonal antibody targeting EGFR, shows promising results in radioimmunotherapy for EGFR-positive head and neck cancer, with a single dose of 200 microCi (90)Y-DOTA-panitumumab leading to almost complete tumor regression in a mouse model.

The treatment demonstrated significant tumor growth delay and improved survival, while also showing limited systemic toxicity, indicating its potential as a safe and effective option for treating EGFR-positive solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidermal growth factor receptor-targeted radioimmunotherapy of human head and neck cancer xenografts using 90Y-labeled fully human antibody panitumumab. Liu, Z., Liu, Y., Jia, B., et al.[2023]

Panitumumab, a monoclonal antibody for treating EGFR positive colorectal cancer, has been successfully radiolabeled with (89)Zr, showing high radiochemical yield (>70%) and purity (>98%), making it suitable for use as an immuno-PET probe.

The developed synthesis and quality control process for (89)Zr-panitumumab is efficient, taking about 5 hours, and includes rapid in-process QC tests to ensure safety and reliability for human injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of clinical-grade (89) Zr-panitumumab as a positron emission tomography biomarker for evaluating epidermal growth factor receptor-targeted therapy. Wei, L., Shi, J., Afari, G., et al.[2023]

References

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

Panitumumab (vectibix). [2021]

2. 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]

3. 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]

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

Performance of immuno-positron emission tomography with zirconium-89-labeled chimeric monoclonal antibody U36 in the detection of lymph node metastases in head and neck cancer patients. [2015]

5. 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]

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

Zirconium-89 labeled panitumumab: a potential immuno-PET probe for HER1-expressing carcinomas. [2022]

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

89Zr-panitumumab Combined With 18F-FDG PET Improves Detection and Staging of Head and Neck Squamous Cell Carcinoma. [2023]

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

Epidermal growth factor receptor-targeted radioimmunotherapy of human head and neck cancer xenografts using 90Y-labeled fully human antibody panitumumab. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Preparation of clinical-grade (89) Zr-panitumumab as a positron emission tomography biomarker for evaluating epidermal growth factor receptor-targeted therapy. [2023]