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Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma
Phase 1
Waitlist Available
Led By Kiarash Shahlaie
Research Sponsored by Kiarash Shahlaie, M.D., Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 says after surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the effects of injecting lidocaine into patients with glioblastoma during their brain tumor surgery. Lidocaine helps to relieve pain by blocking nerve signals. Researchers hope this will lead to better treatments for glioblastoma in the future. Lidocaine has been used for pain relief in various medical contexts, including surgery and cancer treatment.
Eligible Conditions
- Glioblastoma
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 says after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 says after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference between the concentrations of lidocaine in the tumor tissue and in the blood (baseline level)
Secondary study objectives
Incidence of adverse events (AEs)
Overall survival (OS)
Progression free survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Health services research (lidocaine, surgery)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Lidocaine
2011
Completed Phase 4
~1370
Resection
2020
Completed Phase 2
~1440
Find a Location
Who is running the clinical trial?
Kiarash Shahlaie, M.D., Ph.D.Lead Sponsor
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,158 Total Patients Enrolled
330 Trials studying Glioblastoma
23,368 Patients Enrolled for Glioblastoma
Kiarash ShahlaiePrincipal Investigator - University of California, Davis
Sutter General Hospital, University of California-Davis Medical Center
University Of California (Medical School)
University Ca Davis Health System (Residency)