111In-Panitumumab for Head and Neck Cancer

Overseen By Tiffany Park

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Must not be taking: Class IA, Class III antiarrhythmics

Disqualifiers: Myocardial infarction, Uncontrolled CHF, others

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

Compensation: Varies

Number of Visits: 2

Duration: Up to Day of Surgery

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, 111In-panitumumab, for individuals with head and neck squamous cell carcinoma. The main goal is to determine if this agent safely and effectively helps doctors identify cancerous lymph nodes before surgery. Participants must have a confirmed diagnosis of this cancer and be scheduled for surgical removal. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

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. However, if you are taking certain heart rhythm medications (like quinidine, procainamide, dofetilide, amiodarone, or sotalol), you may not be eligible to participate.

Is there any evidence suggesting that 111In-panitumumab is likely to be safe for humans?

Research has shown that 111In-panitumumab is under study to determine its safety as an imaging tool. It is being tested for its ability to identify important lymph nodes in patients with head and neck cancer. As these studies are in the early stages, limited information is available about its safety in humans.

111In-panitumumab is part of a phase 1 trial, the initial step in testing, which primarily assesses safety. Although data is limited, early trials are designed to monitor side effects closely and evaluate patient tolerance. If this treatment were approved for another condition, it would indicate some level of safety, but that is not the case here.

Participants in these trials are closely monitored for any adverse effects. Those considering joining this trial should discuss potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for head and neck cancer, which often include surgery, radiation, and chemotherapy, 111In-Panitumumab is unique because it combines a targeted approach with imaging capabilities. This treatment uses a radiolabeled antibody, 111In-Panitumumab, which specifically targets cancer cells, potentially offering more precise treatment while minimizing damage to healthy tissue. Additionally, it allows doctors to visualize the cancer through SPECT/CT imaging, providing valuable insights into the tumor's characteristics and behavior. Researchers are excited because this dual function of targeting and imaging could lead to more personalized and effective treatment plans for patients.

What evidence suggests that 111In-panitumumab is effective for imaging in head and neck cancer?

Research has shown that using 111In-panitumumab with SPECT/CT imaging might help doctors better locate sentinel lymph nodes in patients with head and neck squamous cell cancer. Identifying these lymph nodes is crucial for guiding treatment choices. Previous studies have demonstrated that panitumumab, the main ingredient, can help prevent disease progression, even if it does not shrink tumors. In this trial, combining 111In, a radioactive tracer, with panitumumab aims to enhance imaging results. Although more information is needed, early findings suggest it could improve cancer staging. ^{4 6 7 8 9}

Who Is on the Research Team?

Fred Baik, MD

Principal Investigator

Stanford Universiy

Are You a Good Fit for This Trial?

This trial is for individuals with any stage of head and neck squamous cell carcinoma, scheduled for surgery. They must have acceptable blood counts, kidney, and liver function. Excluded are those with recent severe heart issues, interstitial pneumonitis or pulmonary fibrosis, low magnesium/potassium levels, certain antiarrhythmic drugs usage, history of monoclonal antibody infusion reactions, severe renal disease/anuria or who are pregnant/breastfeeding.

Inclusion Criteria

I am scheduled for surgery for my head or neck cancer, which may be a recurrence or a new diagnosis.

I am scheduled for neck surgery to remove lymph nodes due to my cancer.

I have been diagnosed with squamous cell carcinoma in the head or neck.

Exclusion Criteria

Magnesium or potassium lower than the normal institutional values.

I am taking specific medications for heart rhythm problems.

I have had interstitial pneumonitis or pulmonary fibrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Administration of 111In-panitumumab and SPECT/CT imaging

Up to Day of Surgery

1 visit (in-person) for drug administration and imaging

Surgery

Surgical resection after infusion of 111In-panitumumab

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 days

Follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• 111In-Panitumumab

Trial Overview The study tests the safety of a molecular imaging agent called 111In-panitumumab in patients with head and neck cancer. It also compares the effectiveness of identifying sentinel lymph nodes using this agent before surgery versus conventional dye injection at surgery time.

How Is the Trial Designed?

Group I: 111-In panitumumab Experimental Treatment 2 Interventions

The study drug (111In panitumumab) 5 mCi, allowable range 4.5 to 5.5 will be administered on Day 0, and subjects will undergo one 111In panitumumab SPECT/CT imaging anytime between Day 1 and Day of Surgery. Subjects will undergo surgical resection after infusion of 111In 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+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

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 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 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]

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]

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]

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/415380

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00460265

NCT00460265 | Study of Panitumumab Efficacy in Patients ... The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy.

3. theranostictrials.org theranostictrials.org/studies/cl74bp9il0253ajjfrinr5n8z

Head and Neck Cancers Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing ...

4. withpower.com withpower.com/trial/phase-1-head-and-neck-neoplasms-2-2021-8ab28

111In-Panitumumab for Head and Neck Cancer This Phase 1 medical study run by Stanford University is evaluating whether 111In-Panitumumab will have tolerable side effects & efficacy for patients with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5507653/

Multicenter Phase II Study of Panitumumab in Platinum ... Panitumumab shows activity in terms of disease control rate and preventing disease progression but not for tumor shrinkage in head and neck squamous cell ...

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

111In-Panitumumab for Nodal Staging in Patients with ... 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. 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 ...

8. 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 has ...

9. 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 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 ...