Clinical trial NCT04716699: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glioblastoma
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-01-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Difference between the concentrations of lidocaine in the tumor tissue and in the blood (baseline level)
timeFrame: At start of surgery up until completion of surgery, assessed up to 4 hours after starting surgery
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: From diagnosis to first documented evidence of disease progression or death, whichever comes first, assessed up to 30 days after surgery
measure: Overall survival (OS)
timeFrame: From diagnosis to death, assessed up to 30 days after surgery
measure: Incidence of adverse events (AEs)
timeFrame: Up to 30 says after surgery
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, Davis
name: Kiarash Shahlaie
role: PRINCIPAL_INVESTIGATOR
References: