GlioblastomaPhase 1NCT04716699
Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma
A Phase 1 study testing Biospecimen Collection, Lidocaine and Resection in people with Glioblastoma, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Biospecimen Collection, Lidocaine and Resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 24 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 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
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: Assessing Systemic and Local Levels of Lidocaine During Surgery for Glioblastoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the pharmacokinetic properties of intravenously administered lidocaine inside a glioblastoma tumor by means of mass spectroscopy.
SECONDARY OBJECTIVE:
- 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.
- Conditions
- Glioblastoma
- Being tested
- Biospecimen Collection, Lidocaine, Resection
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood and tumor samples
LidocaineDrug
Also called .omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2'',6''-acetoxylidide, Cuivasil, Duncaine
Given IV
ResectionProcedure or surgery
Also called Surgical Resection
Undergo surgical resection per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Health services research (lidocaine, surgery) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Drug: Lidocaine; Procedure: Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the concentrations of lidocaine in the tumor tissue and in the blood (baseline level)
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.
Measured: At start of surgery up until completion of surgery, assessed up to 4 hours after starting surgery
Secondary outcomes (3)
Progression free survival (PFS)
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.
Measured: From diagnosis to first documented evidence of disease progression or death, whichever comes first, assessed up to 30 days after surgery
Overall survival (OS)
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.
Measured: From diagnosis to death, assessed up to 30 days after surgery
Incidence of adverse events (AEs)
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.
Measured: Up to 30 says after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start20 Jan 2021
- Primary completion26 Dec 2021
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kiarash Shahlaie, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716699
- Sponsor's protocol ID
- UCDCC#285
- Other IDs
- NCI-2020-14099, UCDCC#285, P30CA093373
- Status last verified
- May 2025
- First submitted
- 15 Jan 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Riestenberg RA, Goodarzi A, Goodrich D, Clouse J, Ling S, Lechpammer M, Schloemerkemper N, Chen S, Chen Y, Bloch O, Shahlaie K. Pharmacokinetics of lidocaine infusion during surgery for glioblastoma. Clin Neurol Neurosurg. 2025 Dec;259:109218. doi: 10.1016/j.clineuro.2025.109218. Epub 2025 Oct 26.
PubMed 41177142
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Systemic and Local Levels of Lidocaine During Surgery for Glioblastoma
- ClinicalTrials.gov ID
- NCT04716699
- Acronym / sponsor ID
- UCDCC#285
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 26 Dec 2021 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the pharmacokinetic properties of intravenously administered lidocaine inside a glioblastoma tumor by means of mass spectroscopy.
SECONDARY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (lidocaine, surgery) | Experimental | Procedure: Biospecimen Collection, Drug: Lidocaine, Procedure: ResectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >= 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood and tumor samples | Procedure or surgery | Health services research (lidocaine, surgery) |
| LidocaineAlso: .omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2'',6''-acetoxylidide, Cuivasil, DuncaineGiven IV | Drug | Health services research (lidocaine, surgery) |
| ResectionAlso: Surgical ResectionUndergo surgical resection per standard of care | Procedure or surgery | Health services research (lidocaine, surgery) |
Primary outcome
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.
3 secondary outcomes
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
Overall survival (OS)
Time frame: From diagnosis to death, assessed up to 30 days after surgery
Incidence of adverse events (AEs)
Time frame: Up to 30 says after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 41177142Riestenberg RA, Goodarzi A, Goodrich D, Clouse J, Ling S, Lechpammer M, Schloemerkemper N, Chen S, Chen Y, Bloch O, Shahlaie K. Pharmacokinetics of lidocaine infusion during surgery for glioblastoma. Clin Neurol Neurosurg. 2025 Dec;259:109218. doi: 10.1016/j.clineuro.2025.109218. Epub 2025 Oct 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiarash Shahlaie principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biospecimen Collection, Lidocaine and Resection in people with Glioblastoma, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04716699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.