Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma

NCT04716699 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: UCDCC#285NCI-2020-14099P30CA093373
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial measures the amount and effect of lidocaine injected into patients with glioblastoma while they are undergoing surgical removal of their brain tumors. Lidocaine is a substance used to relieve pain by blocking signals at the nerve endings in skin. Information gained from this study may help researchers come up with new treatments to help patients with glioblastomas in the future.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Difference between the concentrations of lidocaine in the tumor tissue and in the blood (baseline level)

  Analysis is mainly descriptive and will be mainly done by Lidocaine analysis lab. Will report the mean and standard deviation of concentration of lidocaine in the tumor and blood at 3 time points. The pharmacokinetics of lidocaine within the tumor will be summarized using the means, and standard pharmacokinetics parameters will be reported (maximum concentration, time of maximum concentration, and area under the curve). If applicable, will use mixed effects model to summarize trajectories of change for concentration measured at multiple time points, which will account for correlation between repeated measures within patient.

  At start of surgery up until completion of surgery, assessed up to 4 hours after starting surgery

Secondary Outcomes (3)

• Progression free survival (PFS)

  From diagnosis to first documented evidence of disease progression or death, whichever comes first, assessed up to 30 days after surgery

• Overall survival (OS)

  From diagnosis to death, assessed up to 30 days after surgery

• Incidence of adverse events (AEs)

  Up to 30 says after surgery

Study Arms (1)

Health services research (lidocaine, surgery)

EXPERIMENTAL

Patients receive bolus lidocaine IV per standard of care. After intubation, patients receive another infusion of lidocaine IV over 4 hours or until the end of surgery. Patients also undergo collection of blood and tumor samples at the start of surgery and hourly afterwards until a total of 4 samples are collected.

Procedure: Biospecimen Collection; Drug: Lidocaine; Procedure: Resection

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood and tumor samples

Health services research (lidocaine, surgery)

Lidocaine DRUG

Given IV

Also known as: .omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2'',6''-acetoxylidide, Cuivasil, Duncaine, Leostesin, Lidothesin, Lignocaine, Rucaina

Health services research (lidocaine, surgery)

Resection PROCEDURE

Undergo surgical resection per standard of care

Also known as: Surgical Resection

Health services research (lidocaine, surgery)

Eligibility Criteria

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

You may qualify if:

• \>= 18 years of age
• Preoperative imaging characteristics consistent with brain glioblastoma (magnetic resonance imaging \[MRI\] brain)
• Patients who are undergoing neurosurgical resection for treatment of glioblastoma
• Ability to understand and willingness to sign an informed consent form
• Ability to adhere to the study visit schedule and other protocol requirements

You may not qualify if:

• Prior treatment for glioblastoma
• Glioblastoma size less than 5 cm\^3
• Known allergy against amide type of local anesthetics
• History of severe cardiac failure (determined by clinical history of less the 3 Metabolic Equivalent of Tasks \[METs\])
• nd or 3rd degree heart block (exception: patients with pacemaker)
• Concurrent treatment with class I or III antiarrhythmics (phenytoin, procainamide, propranolol, quinidine) or amiodarone use =\< 3 months
• History of Wolff-Parkinson-White syndrome, Stokes Adams syndrome, or active dysrhythmia
• History of bradycardia
• Prior clinical history of severe hepatic impairment or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.55 times of upper normal limit
• Prior clinical history of severe renal impairment or estimated glomerular filtration rate (EGFR) \< 30ml/min
• Uncontrolled seizure disorder
• Acute porphyria
• Patients requiring an awake fiberoptic intubation due to administration of additional lidocaine
• Pregnant or lactating women
• Any condition that would prohibit the understanding or rendering of informed consent

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of California, Davis: lead

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kiarash Shahlaie

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: January 20, 2021
• Primary Completion: December 26, 2021
• Study Completion: January 24, 2022
• Last Updated: March 10, 2026

Record last verified: 2025-05

Locations

US (1)