Zr-Panitumumab Imaging for Head and Neck Cancer

Overseen By Roan C Raymundo, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Class IA, Class III antiarrhythmics

Disqualifiers: MI, CVA, CHF, pregnancy, 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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new imaging method, 89Zr-panitumumab, in detecting the spread of head and neck cancer. The study compares two groups: one receiving the experimental imaging treatment, 89Zr-panitumumab IV, and another receiving the standard treatment, panitumumab (also known as Vectibix). The trial seeks participants with confirmed squamous cell carcinoma in the head and neck who have undergone a specific scan indicating potential cancer spread within the last month. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it excludes those taking certain heart rhythm medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that 89Zr-panitumumab is generally safe for patients. This imaging agent aids doctors in detecting cancer and presents few safety concerns. However, it involves more radiation exposure than other imaging agents, such as 18F-FDG. While this results in slightly higher radiation levels, no major problems have been reported.

Panitumumab, another component of the study, is an approved treatment for certain cancers, demonstrating that patients tolerate it well. Overall, both treatments have been used without significant safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about 89Zr-panitumumab IV for head and neck cancer because it offers a novel approach by using zirconium-89 labeled panitumumab as a diagnostic imaging agent. This technique allows for precise visualization of cancerous tissues, potentially leading to more accurate assessments of the tumor's response to treatment. Unlike traditional chemotherapy or radiation therapy, which can affect both healthy and cancerous tissues, this imaging method targets specific cancer cells, providing a clearer picture of the disease. By enhancing imaging accuracy, it may improve treatment planning and outcomes for patients with head and neck cancer.

What evidence suggests that 89Zr-panitumumab is effective for diagnosing metastatic lesions in head and neck cancer?

Research has shown that 89Zr-panitumumab is a new imaging tool being tested to detect cancer spread in head and neck cancer patients. When combined with PET/CT scans, this tool enhances the identification of cancerous areas. It targets a protein called EGFR, often found in high amounts in head and neck cancers. Early results suggest that this method is safe and can more accurately distinguish between actual cancer and other scan anomalies.

In this trial, researchers are also studying panitumumab as a treatment option. Panitumumab, a drug that targets EGFR, is already used to treat some cancers by inhibiting cancer cell growth. While panitumumab doesn't directly detect cancer, its known effects on EGFR-related cancers make it valuable in this study. ^{2 3 4 5 6}

Who Is on the Research Team?

Fred Baik, MD

Principal Investigator

Stanford Cancer Institute

Are You a Good Fit for This Trial?

Adults over 19 with a confirmed diagnosis of head and neck squamous cell carcinoma, including those with recurrent disease or new primary. They must have had a PET/CT scan within the last 30 days showing suspected metastatic lesions and meet certain blood, kidney, and liver function criteria. Excluded are pregnant/breastfeeding individuals, those with low magnesium/potassium levels, severe renal issues, known allergies to similar drugs, lung conditions like interstitial pneumonitis or pulmonary fibrosis, or recent significant cardiovascular events.

Inclusion Criteria

My blood, kidney, and liver tests are within the required ranges.

I am 19 years old or older.

I have been diagnosed with head and neck cancer, regardless of its stage or if it has returned.

Exclusion Criteria

I have severe kidney problems or cannot produce urine.

Pregnant or breastfeeding

Known hypersensitivity to deferoxamine or any of its components

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 89Zr-panitumumab IV for the detection of suspected metastatic lesions

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 89Zr-panitumumab IV
• Panitumumab

Trial Overview The trial is testing the effectiveness of an intravenous drug called Zr-Panitumumab in detecting metastatic cancer lesions in patients with head and neck cancers when used alongside standard PET/CT scans.

How Is the Trial Designed?

Group I: 89Zr-panitumumab IV Experimental Treatment 1 Intervention

Subjects will be given 89Zr-panitumumab IV

Group II: panitumumab 30 mg Active Control 1 Intervention

Subjects will be given a 30mg of panitumumab

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Andrei Iagaru

Lead Sponsor

Trials

16

Recruited

600+

Published Research Related to This Trial

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]

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 3 trial involving 657 patients with recurrent or metastatic squamous-cell carcinoma of the head and neck, the addition of panitumumab to chemotherapy improved progression-free survival (5.8 months vs. 4.6 months) but did not significantly enhance overall survival compared to chemotherapy alone.

The study found that p16 status may serve as a prognostic and predictive biomarker, with p16-negative patients experiencing longer overall survival with panitumumab compared to the control group, suggesting that p16 status could help tailor treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Vermorken, JB., Stöhlmacher-Williams, J., Davidenko, I., et al.[2022]

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]

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]

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 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]

Citations

1. aacrjournals.org aacrjournals.org/clincancerres/article/28/20/4425/709598/89Zr-panitumumab-Combined-With-18F-FDG-PET

89 Zr-panitumumab Combined With 18 F-FDG PET Improves ... We found that the use of 89Zr-pan PET/CT led to improved specificity and positive predictive value in detection of metastatic head and neck ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35929985/

89Zr-panitumumab Combined With 18F-FDG PET Improves ... 89Zr-pan PET/CT imaging is safe and may be valuable in discriminating incidental findings identified on 18F-FDG PET/CT from true positive lesions and in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05747625

NCT05747625 | (89Zr Panitumumab) With PET/CT for ... 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5596322/

Dosimetry and first human experience with 89Zr- ... Our objective was to calculate the maximum dosing for effective imaging with minimal radiation exposure in a small subset. Three patients with metastatic colon ...

5. withpower.com withpower.com/trial/phase-2-carcinoma-5-2022-a1750

Zr-Panitumumab Imaging for Head and Neck Cancer The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous ...

6. withpower.com withpower.com/trial/early-phase-1-carcinoma-squamous-cell-2-2022-dcb92

[89Zr]Panitumumab Imaging for Head and Neck Cancer This trial tests a new imaging method using a special radioactive substance to better locate and measure head and neck tumors in patients.