Imaging with 111In Panitumumab for Head and Neck Cancer

Overseen By Nicole Jones

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vanderbilt-Ingram Cancer Center

Must not be taking: Antiarrhythmics

Disqualifiers: Myocardial infarction, CHF, allergies, others

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

Compensation: Varies

Number of Visits: 3

Duration: 5 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help doctors determine if head and neck cancer has spread to the lymph nodes. It uses 111In-panitumumab, a special drug that combines a radioactive substance with an antibody to bind to cancer cells, making them visible through a detailed imaging scan. This technique could help identify cancerous nodes too small for regular methods to detect. Individuals with a confirmed diagnosis of head and neck squamous cell carcinoma who are scheduled for surgery might be suitable candidates for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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

The trial 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 prior data suggests that 111In-panitumumab is safe for identifying sentinel lymph nodes in head and neck cancer patients?

Research is investigating the safety of indium In 111 panitumumab (111In-panitumumab) for people with head and neck cancer. This treatment combines a radioactive substance with a special protein that targets cancer cells. The studies primarily aim to determine if it can safely highlight cancer-affected lymph nodes in imaging scans.

As a phase 1 trial, this marks the first step in human testing. In this phase, doctors closely monitor side effects and the body's response to the treatment. With no previous data on tolerance for this specific treatment, the trial carefully observes for any negative reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Indium In 111 Panitumumab for head and neck cancer because it offers a new way to see cancer cells more clearly. Unlike standard treatments that primarily focus on shrinking or removing tumors, this technique uses a radioactive tracer to enhance imaging with SPECT/CT scans, helping doctors pinpoint the cancer's exact location. Additionally, this method combines optical dye and near-infrared (NIR) imaging during surgery, which could improve the precision of tumor removal and potentially lead to better outcomes for patients.

What evidence suggests that this imaging technique is effective for identifying sentinel lymph nodes in head and neck cancer?

Research has shown that indium In 111 panitumumab (111In-panitumumab), which participants in this trial will receive, might help detect cancer spread in head and neck cancer. This substance binds to a protein on many cancer cells, making them visible in scans. Studies indicate that using it with SPECT/CT scans can better identify sentinel lymph nodes, crucial for predicting cancer spread. Early results suggest this method might be more accurate than traditional ones. ^{6 7 8 9 10}

Who Is on the Research Team?

Eben Rosenthal, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 19 with a confirmed diagnosis of head and neck squamous cell carcinoma, who are scheduled for surgical resection. They must have acceptable blood counts, kidney and liver function, but can't join if they've had recent severe heart issues, allergies to iodine or monoclonal antibodies, low magnesium or potassium levels, certain antiarrhythmic drugs in their system, or severe kidney problems.

Inclusion Criteria

I am scheduled for a neck surgery to remove lymph nodes.

My cancer is a type of skin cancer in the head or neck area, and it hasn't spread to my lymph nodes.

My blood, kidney, and liver tests meet the required levels.

Exclusion Criteria

Pregnant or breastfeeding

History of infusion reactions to monoclonal antibody therapies

History of allergies to iodine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a loading dose of panitumumab IV followed by 111In-panitumumab IV bolus on day 0, and undergo SPECT/CT scan between day 1 and day of surgery

5 days

Multiple visits (in-person) for treatment and imaging

Surgery

Standard of care surgery with local injection of optical dye and intraoperative imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 days

1 visit (in-person) on day 15 if indicated

What Are the Treatments Tested in This Trial?

Interventions

• Indium In 111 Panitumumab
• Panitumumab

Trial Overview The trial tests the safety and effectiveness of a radioactive drug called indium In 111 panitumumab (111In-panitumumab) combined with SPECT/CT imaging to identify sentinel lymph nodes affected by cancer in patients undergoing surgery for head and neck cancer.

How Is the Trial Designed?

Group I: Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) Experimental Treatment 10 Interventions

Patients receive loading dose of panitumumab IV over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

In a phase 2 study involving 103 patients with recurrent/metastatic squamous cell carcinoma of the head and neck, the addition of panitumumab to docetaxel/cisplatin chemotherapy improved progression-free survival (PFS) to 6.9 months compared to 5.5 months for chemotherapy alone.

While the combination therapy showed a higher overall response rate (44% vs. 37%), it also resulted in a higher incidence of grade 3/4 adverse events (73% vs. 56%), indicating a trade-off between efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PARTNER: An open-label, randomized, phase 2 study of docetaxel/cisplatin chemotherapy with or without panitumumab as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck. Wirth, LJ., Dakhil, S., Kornek, G., et al.[2019]

Cetuximab is associated with a lower incidence of severe skin toxicities compared to panitumumab, making it potentially safer for patients in terms of skin-related side effects.

While cetuximab may cause slightly more acne-like rashes and paronychia, it results in fewer cases of skin fissures and itching, indicating distinct toxicity profiles between the two treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Toxicity of Cetuximab and Panitumumab in Metastatic Colorectal Cancer Treatment: A Systematic Review and Meta-Analysis. Petrelli, F., Ardito, R., Ghidini, A., et al.[2018]

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, an anti-EGFR monoclonal antibody, significantly improves progression-free survival when combined with chemotherapy in patients with wild-type KRAS metastatic colorectal cancer, but shows no overall survival benefit in second-line treatment.

In patients with mutant KRAS tumors, panitumumab is less effective, leading to shorter progression-free survival when combined with certain chemotherapy regimens, highlighting the importance of KRAS mutation status in treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on panitumumab in metastatic colorectal cancer. Keating, GM.[2018]

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]

A study using a fluorescently-labeled tumor-targeting agent, panitumumab-IRDye800CW, showed that it significantly enhances the identification of metastatic lymph nodes (LNs) in head and neck cancer patients during surgery.

This molecular imaging technique allows for a more focused evaluation of LNs, potentially improving prognostic accuracy compared to traditional methods of neck dissection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical molecular imaging can differentiate metastatic from benign lymph nodes in head and neck cancer. Nishio, N., van den Berg, NS., van Keulen, S., et al.[2022]

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 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]

(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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05945875

Study Details | NCT05945875 | Evaluating the Use of Dual ... This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon ...

2. cancer.gov cancer.gov/clinicaltrials/NCI-2023-03821

111In-Panitumumab for Nodal Staging in Patients with ... Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing ...

3. trialx.com trialx.com/clinical-trials/listings/237407/evaluating-the-use-of-dual-imaging-techniques-for-detection-of-disease-in-patients-with-head-and-neck-cancer/?&radius=10&place=All%20Participating%20Sites&user_country=Germany

Evaluating the Use of Dual Imaging Techniques ... This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with ...

4. vicc.org vicc.org/clinical-trials/search?cancer-type=Endocrine&f%5B0%5D=disease_site%3AHead/Neck&f%5B1%5D=drug_name%3ANot%20Available&f%5B2%5D=drug_name%3APF-06840003&keys=

Clinical Trials Search at Vanderbilt-Ingram Cancer Center Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing ...

5. withpower.com withpower.com/trial/phase-1-carcinoma-7-2023-e8847

Dual Imaging for Head and Neck Cancer This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05901545

Evaluating 111In Panitumumab for Nodal Staging in Head ... This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-05694

111In Panitumumab for Nodal Staging in Head and Neck ... This phase I trial studies the side effects of 111In-panitumumab for nodal staging of head of neck cancer. Often cancerous cells have unusual proteins on ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05945875

Study Details | NCT05945875 | Evaluating the Use of Dual ... This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon ...

9. stanfordhealthcare.org stanfordhealthcare.org/trials/s/NCT04840472.html

Study Evaluating 111In-Panitumumab for Nodal Staging in ... The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell ...

10. theranostictrials.org theranostictrials.org/studies/cl74bp9il0253ajjfrinr5n8z/study/NCT05901545

NCT05901545 This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer ...