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
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Procedure: Biospecimen Collection Drug: Lidocaine Procedure: Resection||Phase 1|
I. To assess the pharmacokinetic properties of intravenously administered lidocaine inside a glioblastoma tumor by means of mass spectroscopy.
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.
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.
|Study Type :||Interventional|
|Estimated Enrollment :||12 participants|
|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|
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
Undergo surgical resection per standard of care
Other Name: Surgical Resection
- 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.
- 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.
- 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.
- 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.
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
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Kiarash Shahlaie, MD 916-734-6511 firstname.lastname@example.org|
|Principal Investigator: Kiarash Shahlaie|
|Principal Investigator:||Kiarash Shahlaie||University of California, Davis|