Clinical Trials /

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

NCT04716699

Description:

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.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04716699

Trial Eligibility

Document

Title

  • Brief Title: Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma
  • Official Title: Assessing Systemic and Local Levels of Lidocaine During Surgery for Glioblastoma

Clinical Trial IDs

  • ORG STUDY ID: UCDCC#285
  • SECONDARY ID: NCI-2020-14099
  • SECONDARY ID: UCDCC#285
  • SECONDARY ID: P30CA093373
  • NCT ID: NCT04716699

Conditions

  • Glioblastoma

Interventions

DrugSynonymsArms
Lidocaine.omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2'',6''-acetoxylidide, Cuivasil, Duncaine, Leostesin, Lidothesin, Lignocaine, RucainaHealth services research (lidocaine, surgery)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Health services research (lidocaine, surgery)ExperimentalPatients 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.
  • Lidocaine

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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Difference between the concentrations of lidocaine in the tumor tissue and in the blood (baseline level)
Time Frame:At start of surgery up until completion of surgery, assessed up to 4 hours after starting surgery
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:From diagnosis to first documented evidence of disease progression or death, whichever comes first, assessed up to 30 days after surgery
Safety Issue:
Description:Kaplan-Meier plots and confidence intervals will be used to summarize PFS. Medians (and associated 95% confidence intervals) of PFS will then be calculated and compared with historical control from the literature.
Measure:Overall survival (OS)
Time Frame:From diagnosis to death, assessed up to 30 days after surgery
Safety Issue:
Description:Kaplan-Meier plots and confidence intervals will be used to summarize OS. Medians (and associated 95% confidence intervals) of OS will then be calculated and compared with historical control from the literature.
Measure:Incidence of adverse events (AEs)
Time Frame:Up to 30 says after surgery
Safety Issue:
Description:Will record safety and toxicity profile using National Cancer Institute Common Terminology Criteria for Adverse Events 5.0. AEs will be summarized using descriptive statistics. The type, grade, frequency and proportion of toxicities will be reported, along with associated 95% confidence interval of proportion.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kiarash Shahlaie, M.D., Ph.D.

Last Updated

January 22, 2021