Panitumumab for Head and Neck Cancer

Overseen By Carleigh Burns

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Vanderbilt-Ingram Cancer Center

Must not be taking: Antiarrhythmics

Disqualifiers: Infusion reactions, Pulmonary fibrosis, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 21 days

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Panitumumab, a drug approved for other cancers, to evaluate its effectiveness for head and neck cancer. The study uses a modified version of the drug combined with a dye to help surgeons see cancer cells more clearly during surgery. The main goal is to determine the right dose that is both safe and effective. Individuals with head and neck cancer who are planning to undergo surgery might be suitable candidates for this trial. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically Class IA and Class III antiarrhythmic agents, at least 30 days before participating. If you are on these medications, you would be ineligible for the trial.

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

Previous studies have shown that Panitumumab-IRDye800 is safe and stable. Research indicates that only about 7.4% of participants experienced side effects, none of which were severe. This suggests that most people did not have serious reactions. Since Panitumumab is already approved for treating other cancers, such as colorectal cancer, there is some confidence in its safety. The dye component, IRDye800, has been tested in the lab and helps doctors see cancer cells more clearly during surgery. Overall, evidence suggests that this combination is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Panitumumab IRDye 800 for head and neck cancer because it introduces a novel approach with its unique mechanism. Unlike traditional treatments that might involve surgery, radiation, or chemotherapy targeting rapidly dividing cells, Panitumumab IRDye 800 combines an antibody targeting the EGFR (epidermal growth factor receptor) with a fluorescent dye. This allows for precise targeting of cancer cells, potentially enhancing the accuracy of surgical removal and minimizing damage to healthy tissue. This dual-action approach not only aids in treatment but also in diagnostics, offering a promising advance over existing therapies.

What evidence suggests that Panitumumab IRDye 800 might be an effective treatment for head and neck cancer?

Research has shown that Panitumumab, also known as Vectibix, treats certain cancers, such as colorectal cancer. It works by attaching to cancer cells, aiding in their targeting and destruction. Early findings suggest that adding a special dye called IRDye800 to Panitumumab can help doctors see cancer cells more clearly during surgery. This combination could help surgeons better distinguish between cancerous and healthy tissues. Studies have demonstrated that this method improves cancer detection and has few side effects. This trial will evaluate Panitumumab-IRDye800 in treating head and neck cancer, with different cohorts receiving varying doses to assess its effectiveness and safety. ^{2 4 5 6 7}

Who Is on the Research Team?

Eben L Rosenthal, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with head and neck squamous cell carcinoma planning to undergo surgery. Participants must have normal organ function, agree to use contraception if of childbearing potential, and not be pregnant or breastfeeding. Exclusions include severe allergies to certain antibodies, specific heart conditions, electrolyte imbalances that can't be corrected, active tuberculosis, lung fibrosis except certain types from radiation therapy.

Inclusion Criteria

I am scheduled for surgery to remove my cancer.

Willing to review and sign written informed consent

I am over 18 years old.

Exclusion Criteria

History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

I am not taking specific heart rhythm medications that could interact with the trial drug.

Patients with a history of infusion reactions or allergic reactions to panitumumab

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one or two doses of Panitumumab and Panitumumab-IRDye800 to assess tumor drug concentration and imaging efficacy

Up to 21 days

Surgery

Intraoperative use of Panitumumab-IRDye800 to optimize surgical margins and identify malignant lymph nodes

Single surgical event

Follow-up

Participants are monitored for safety and effectiveness after treatment and surgery

Up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

• Panitumumab IRDye 800

Trial Overview

The study tests Panitumumab-IRDye800 in patients with head and neck cancer during surgery. It combines the approved drug Panitumumab (Vectibix) with a fluorescent dye IRDye800 to make cancer cells visible using a special camera. The aim is to find the optimal dose that's effective for treating cancer without causing sickness.

How Is the Trial Designed?

Group I: Cohort 2a - Cohort 2c Experimental Treatment 1 Intervention

These cohorts will receive one dose of Pan800 and and two doses of Panitumumab at a range of doses (varying of specific cohort).

Group II: Cohort 1a - Cohort 1c Experimental Treatment 1 Intervention

These cohorts will receive one dose each of Pan800 (50 mg) and Panitumumab at a range of doses (varying of specific cohort).

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

Published Research Related to This Trial

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 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 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 study involving 24 patients with head and neck squamous cell carcinoma, a fixed dose of 50 mg of the fluorescently labeled antibody panitumumab-IRDye800CW was identified as the optimal dose for enhancing fluorescence during surgery.

The study found that reducing the time between infusion and surgery to within 2 days significantly increased the fluorescence intensity of the tumors, suggesting that timing is crucial for effective imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Dosing Strategy for Fluorescence-Guided Surgery with Panitumumab-IRDye800CW in Head and Neck Cancer. Nishio, N., van den Berg, NS., van Keulen, S., et al.[2021]

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 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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3595117/

Use of Panitumumab-IRDye800 to Image Microscopic ...

Disease detection was significantly improved with panitumumab-IRDye compared to IgG-IRDye800 (P<0.05). Tissue biopsies (average size=3.7mm) positive for ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02415881

Panitumumab IRDye800 Optical Imaging Study

This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 used in subjects with head and neck ...

3.

withpower.com

withpower.com/trial/panitumumab-for-head-and-neck-cancer-1733d

Panitumumab for Head and Neck Cancer

Panitumumab, including its variant Panitumumab-IRDye800CW, has been shown to have minimal toxicities in human trials, with no severe adverse reactions reported.

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06819228/window-trial-of-fluorescently-labeled-panitumumab-panitumumab-irdye800-in-head-and-neck-cancer

Window Trial of Fluorescently Labeled Panitumumab ...

This study is exploring the use of Panitumumab in Head and Neck Cancer. Panitumumab is an approved drug named Vectibix and is used as an ...

5.

vicc.org

vicc.org/clinical-trials/protocol-vicchn21109

Phase II Panitumumab-IRDye800 in Head & Neck Cancer

The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and the further ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29721094/

Safety of panitumumab-IRDye800CW and cetuximab ...

Safety of panitumumab-IRDye800CW and cetuximab-IRDye800CW for fluorescence-guided surgical navigation in head and neck cancers.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32880818/

Safety and Stability of Antibody-Dye Conjugate in Optical ...

Conclusions: Panitumumab-IRDye800CW was safe and stable to administer over a 54-month window with a low rate of adverse events (7.4 %) which is ...