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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04716699
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kiarash Shahlaie, M.D., Ph.D.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kiarash Shahlaie
Principal Investigator Affiliation University of California, Davis
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional 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.

Arms & Interventions

Arms

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.

Interventions

Procedure: - Biospecimen Collection

Undergo collection of blood and tumor samples

Drug: - Lidocaine

Given IV

Procedure: - Resection

Undergo surgical resection per standard of care

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sacramento, California

Status

Address

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817