Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California
Dates
study started
estimated completion
Principal Investigator
by Kiarash Shahlaie

Description

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.

Official Title

Assessing Systemic and Local Levels of Lidocaine During Surgery for Glioblastoma

Details

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.

Keywords

Glioblastoma Lidocaine Biospecimen Collection Resection Health services research (lidocaine, surgery)

Eligibility

You can join if…

Open to people ages 18 years and up

  • >= 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 CAN'T join if...

  • Prior treatment for glioblastoma
  • Glioblastoma size less than 5 cm3

  • 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

Location

  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UC Davis

  • Kiarash Shahlaie
    Professor, Neurological Surgery. Authored (or co-authored) 85 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kiarash Shahlaie, M.D., Ph.D.
Links
Sign up for this study
ID
NCT04716699
Phase
Phase 1
Study Type
Interventional
Last Updated