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

Primary Purpose

Glioblastoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Lidocaine
Resection
Sponsored by
Kiarash Shahlaie, M.D., Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health services research (lidocaine, surgery)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression free survival (PFS)
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.
Overall survival (OS)
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.
Incidence of adverse events (AEs)
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.

Full Information

First Posted
January 15, 2021
Last Updated
April 7, 2023
Sponsor
Kiarash Shahlaie, M.D., Ph.D.
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04716699
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
December 26, 2021 (Actual)
Study Completion Date
January 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kiarash Shahlaie, M.D., Ph.D.
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health services research (lidocaine, surgery)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Intervention Description
Undergo collection of blood and tumor samples
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
.omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2'',6''-acetoxylidide, Cuivasil, Duncaine, Leostesin, Lidothesin, Lignocaine, Rucaina
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Resection
Other Intervention Name(s)
Surgical Resection
Intervention Description
Undergo surgical resection per standard of care
Primary Outcome Measure Information:
Title
Difference between the concentrations of lidocaine in the tumor tissue and in the blood (baseline level)
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.
Time Frame
At start of surgery up until completion of surgery, assessed up to 4 hours after starting surgery
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
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.
Time Frame
From diagnosis to first documented evidence of disease progression or death, whichever comes first, assessed up to 30 days after surgery
Title
Overall survival (OS)
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.
Time Frame
From diagnosis to death, assessed up to 30 days after surgery
Title
Incidence of adverse events (AEs)
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.
Time Frame
Up to 30 says after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiarash Shahlaie
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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

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