Zr-Panitumumab Imaging for Head and Neck Cancer

Overseen By Roan C Raymundo, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Andrei Iagaru

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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 cell carcinoma (HNSCC).

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.

What data supports the effectiveness of the drug 89Zr-panitumumab IV, Panitumumab, Vectibix for head and neck cancer?

Research shows that panitumumab, when used with other treatments like radiotherapy or chemotherapy, can improve outcomes for patients with head and neck cancer. It targets the EGFR pathway, which is important in the growth of cancer cells, and has been studied in various trials for its potential to enhance treatment effectiveness. ^{1 2 3 4 5}

Is panitumumab safe for use in humans?

Panitumumab has been studied in combination with other treatments for head and neck cancer, and while it has shown potential benefits, the studies also assess its safety. In trials, panitumumab combined with other therapies was generally well-tolerated, but like many cancer treatments, it can have side effects, which should be discussed with a healthcare provider. ^{1 2 4 5 6}

How is the Zr-Panitumumab treatment different from other treatments for head and neck cancer?

Zr-Panitumumab is unique because it combines a monoclonal antibody, panitumumab, with a radioactive element, zirconium-89, to improve tumor detection through imaging. This approach, known as immuno-PET, helps in identifying cancer spread more accurately compared to traditional imaging methods. ^{1 2 3 5 7}

Research Team

Judy Nguyen, MD

Principal Investigator

Stanford Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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?

Andrei Iagaru

Lead Sponsor

Trials

16

Recruited

600+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. 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]

2. 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]

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

Panitumumab (vectibix). [2021]

4. England 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. [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

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

7. 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]