Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery

NCT06747390 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: UPCC12324
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Based on evidence that the local anesthetic lidocaine may have anticancer effects, this study will assess the safety and efficacy of intratumoral lidocaine injection at the time of direct laryngoscopy prior to TransOral Robotic Surgery (TORS) and neck dissection for oropharyngeal squamous cell carcinoma (OPSCC). The primary objective of the study is to determine if intratumoral lidocaine injection is safe and causes a major pathologic treatment effect in the primary tumor following surgical resection. The secondary objectives will be to determine if intratumoral lidocaine injection improves locoregional control rates, progression-free survival, metastasis-free survival, and overall survival compared to no injection.

Conditions

Oropharyngeal Squamous Cell Carcinoma (OPSCCA); Oropharyngeal Cancer; Human Papilloma Virus; Squamous Cell Carcinoma

Keywords

TransOral Robotic Surgery (TORS); Oropharyngeal Squamous Cell Carcinoma; Oropharyngeal Cancer; Human Papilloma Virus; Squamous Cell Carcinoma; Lidocaine

Outcome Measures

Primary Outcomes (2)

• Safety measured by occurrence of adverse events.

  Adverse events (AE) and Serious Adverse Events (SAE) will use the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The CTCAE v.5 utilizes a five point scale to report AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.

  2 years

• Pathological tumor response (pTR) in the primary tumor following surgical resection.

  The pathological tumor response (pTR) rate (defined as the area with pathologic response/area pathologic response plus viable tumor) will be determined by the designated study pathologist using increments of 10% for the biopsy and surgery specimens. The scores will be grouped as pTR-0 (\<10%), pTR-1 (10%-49%), and pTR-2 (≥50%).

  2 years

Secondary Outcomes (4)

• 2-year locoregional control rates.

  2 years

• 2-year progression-free survival.

  2 years

• 2-year metastasis-free survival.

  2 years

• 2-year overall survival.

  2 years

Study Arms (2)

Control Arm - No Injection

NO INTERVENTION

No injection at the time of direct laryngoscopy.

Lidocaine Injectible product

EXPERIMENTAL

Intratumoral injection of 1% lidocaine at the time of direct laryngoscopy.

Drug: Lidocaine 1% Injectable Solution

Interventions

Lidocaine 1% Injectable Solution DRUG

1% lidocaine will be injected under direct visualization (not exceeding the maximum tolerated dose of 4.5 mg/kg body weight) into the primary tumor with the aim to distribute the lidocaine evenly into the tumor.

Lidocaine Injectible product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years older or more.
• Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx or neck.
• Clinical T1, T2, T3, or T4 stage disease of the oropharynx (per AJCC 8th Ed).
• Any clinical N stage disease (per AJCC 8th Ed).
• Patients must be undergoing direct laryngoscopy +/- biopsy at the University of Pennsylvania as part of their work-up for consideration of definitive TORS and selective neck dissection.
• Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits.
• Ability to understand and the willingness to provide written informed consent.
• \---

You may not qualify if:

• Prior external beam radiation therapy to the head and neck.
• Prior chemotherapy for head and neck cancer.
• Tumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, or skull base or encases carotid artery (i.e. AJCC 7th Ed. T4b for OPSCC).
• Presence of distant metastatic disease.
• Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
• Known history of hypersensitivity to lidocaine or other amide local anesthetics.
• Pregnant or breastfeeding.

Sponsors & Collaborators

• Ryan Carey: lead

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (3)

• Miller ZA, Mueller A, Kim T, Jolivert JF, Ma RZ, Muthuswami S, Park A, McMahon DB, Nead KT, Carey RM, Lee RJ. Lidocaine induces apoptosis in head and neck squamous cell carcinoma through activation of bitter taste receptor T2R14. Cell Rep. 2023 Dec 26;42(12):113437. doi: 10.1016/j.celrep.2023.113437. Epub 2023 Nov 22.

  PMID: 37995679 BACKGROUND

• Carey RM, McMahon DB, Miller ZA, Kim T, Rajasekaran K, Gopallawa I, Newman JG, Basu D, Nead KT, White EA, Lee RJ. T2R bitter taste receptors regulate apoptosis and may be associated with survival in head and neck squamous cell carcinoma. Mol Oncol. 2022 Apr;16(7):1474-1492. doi: 10.1002/1878-0261.13131. Epub 2021 Dec 14.

  PMID: 34717036 BACKGROUND

• Badwe RA, Parmar V, Nair N, Joshi S, Hawaldar R, Pawar S, Kadayaprath G, Borthakur BB, Rao Thammineedi S, Pandya S, Balasubramanian S, Chitale PV, Neve R, Harris C, Srivastava A, Siddique S, Vanmali VJ, Dewade A, Gaikwad V, Gupta S. Effect of Peritumoral Infiltration of Local Anesthetic Before Surgery on Survival in Early Breast Cancer. J Clin Oncol. 2023 Jun 20;41(18):3318-3328. doi: 10.1200/JCO.22.01966. Epub 2023 Apr 6.

  PMID: 37023374 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms; Carcinoma, Squamous Cell

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ryan Carey, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Carey, MD

CONTACT

2156622777; ryan.carey@pennmedicine.upenn.edu

Prannda Sharma, MS

CONTACT

pranndas@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will be randomized and blinded to intratumoral injection of 1% lidocaine (intervention arm) or no injection (control arm) at the time of direct laryngoscopy.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 24, 2024
• Study Start: April 23, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)