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

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ClinicalTrials.gov Identifier: NCT04716699
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kiarash Shahlaie, M.D., Ph.D., University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Procedure: Biospecimen Collection Drug: Lidocaine Procedure: Resection Phase 1

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.

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Study Type : Interventional
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessing Systemic and Local Levels of Lidocaine During Surgery for Glioblastoma
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : July 20, 2022
Estimated Study Completion Date : January 20, 2023


Arm Intervention/treatment
Experimental: 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.
Procedure: Biospecimen Collection
Undergo collection of blood and tumor samples

Drug: Lidocaine
Given IV
Other Names:
  • .omega.-Diethylamino-2,6-dimethylacetanilide
  • 2-(Diethylamino)-2'',6''-acetoxylidide
  • Cuivasil
  • Duncaine
  • Leostesin
  • Lidothesin
  • Lignocaine
  • Rucaina

Procedure: Resection
Undergo surgical resection per standard of care
Other Name: Surgical Resection




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. Overall survival (OS) [ Time Frame: From diagnosis to death, assessed up to 30 days after surgery ]
    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.

  3. Incidence of adverse events (AEs) [ Time Frame: Up to 30 says after surgery ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716699


Locations
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United States, California
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Kiarash Shahlaie, MD    916-734-6511    krshahlaie@ucdavis.edu   
Principal Investigator: Kiarash Shahlaie         
Sponsors and Collaborators
Kiarash Shahlaie, M.D., Ph.D.
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kiarash Shahlaie University of California, Davis
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Responsible Party: Kiarash Shahlaie, M.D., Ph.D., Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT04716699    
Other Study ID Numbers: UCDCC#285
NCI-2020-14099 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UCDCC#285 ( Other Identifier: University of California Davis Comprehensive Cancer Center )
P30CA093373 ( U.S. NIH Grant/Contract )
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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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
Additional relevant MeSH terms:
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Glioma
Glioblastoma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action