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

Trial Summary

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.

What data supports the effectiveness of the drug 111In-Panitumumab for head and neck cancer?

Research shows that panitumumab, a component of 111In-Panitumumab, has been studied in combination with other treatments for head and neck cancer, suggesting potential benefits when used with radiotherapy and chemotherapy. Panitumumab targets the EGFR pathway, which is involved in the growth of cancer cells, and has been evaluated in various trials for its effectiveness in treating squamous cell carcinoma of the head and neck. ^{1 2 3 4 5}

Is 111In-Panitumumab safe for humans?

The studies mention panitumumab, which is a part of 111In-Panitumumab, being used in combination with other treatments for head and neck cancer. While these studies focus on effectiveness, they suggest that panitumumab has been tested in humans, indicating some level of safety evaluation. ^{1 2 3 5 6}

How is 111In-Panitumumab different from other treatments for head and neck cancer?

111In-Panitumumab is unique because it combines a radioactive element (111In) with panitumumab, a fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFR), potentially enhancing the effectiveness of radiotherapy in treating head and neck cancer. ^{1 2 3 5 6}

What is the purpose of this trial?

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 Carcinoma. The secondary objective is to compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus conventional local injection with an optical dye at the time of surgery.

Research Team

Fred Baik, MD

Principal Investigator

Stanford Universiy

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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 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 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]

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]

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. England 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. [2019]

4. 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]

5. England 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Quality assurance for the EORTC 22071-26071 study: dummy run prospective analysis. [2019]