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

NCT ID: NCT04716699

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2022-01-24

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the pharmacokinetic properties of intravenously administered lidocaine inside a glioblastoma tumor by means of mass spectroscopy.

SECONDARY OBJECTIVE:

I. To assess the differences in overall survival (OS) and progression free survival (PFS) between the patients in the lidocaine therapy group and historical controls taken from the literature (Stupp et al) with comparable post-operative treatment regimen.

OUTLINE:

Patients receive bolus lidocaine intravenously (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.

After completion of surgery, patients are followed for 24 hours, and at 7-14 days, up to 30 days.

Conditions

Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Health services research (lidocaine, surgery)

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.

Group Type: EXPERIMENTAL

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood and tumor samples

Lidocaine

Intervention Type: DRUG

Given IV

Resection

Intervention Type: PROCEDURE

Undergo surgical resection per standard of care

Interventions

Biospecimen Collection

Undergo collection of blood and tumor samples

Intervention Type: PROCEDURE

Lidocaine

Given IV

Intervention Type: DRUG

Resection

Undergo surgical resection per standard of care

Intervention Type: PROCEDURE

Other Intervention Names

.omega.-Diethylamino-2,6-dimethylacetanilide; 2-(Diethylamino)-2'',6''-acetoxylidide; Cuivasil; Duncaine; Leostesin; Lidothesin; Lignocaine; Rucaina; Surgical Resection

Eligibility Criteria

Inclusion Criteria

• >= 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

Exclusion Criteria

• 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])
• 2nd 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
• Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that in the opinion of the investigator would prevent the subject from participating and adhering to study related procedures
• Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient's safety or compliance on trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Kiarash Shahlaie, M.D., Ph.D.

OTHER

Sponsor Role: lead

Responsible Party

Kiarash Shahlaie, M.D., Ph.D.

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kiarash Shahlaie

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Countries

United States

Other Identifiers

NCI-2020-14099

Identifier Type: REGISTRY

Identifier Source: secondary_id

UCDCC#285

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA093373

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCDCC#285

Identifier Type: -

Identifier Source: org_study_id