Protein Phosphatase 2A Inhibitor, in Recurrent Glioblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03027388|
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : April 20, 2020
The brain is separated from the rest of the blood stream by the blood-brain barrier. This is like a filter that protects the brain. But is also a challenge when medicines need to get into the brain. Researchers want to give the new drug LB100 to people before brain tumor surgery. They will measure how much LB100 is in the blood and how much gets into the brain. This may help with the use of LB100 to treat brain tumors in the future.
To see if LB100 can pass into the brain.
People at least 18 years old with a brain tumor that requires surgery
Participants will be screened with:
Tumor sample. This can be from a previous procedure.
Participants will have their brain surgery at the Clinical Center.
Participants will get a dose of the study drug through a plastic tube in a vein for 2 hours during surgery.
Participants will have blood taken 7 times in the 8 hours after getting the study drug.
Tumor samples will be taken during surgery.
Participants will have a heart test after getting the study drug. Sticky pads on the skin will measure electrical activity of the heart.
Two weeks after leaving the hospital, participants will have a follow-up visit. They will have a physical exam and blood tests.
One month after surgery, they will be contacted in person or by phone to see how they are doing.
|Condition or disease||Intervention/treatment||Phase|
|Astrocytoma, Grades II, III and IV Glioblastoma Multiforme Giant Cell Glioblastoma Glioma Oligodendrogliomas||Drug: LB-100||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Phase II Trial of LBlOO, a Protein Phosphatase 2A Inhibitor, in Recurrent Gliomas|
|Actual Study Start Date :||May 9, 2019|
|Estimated Primary Completion Date :||August 30, 2021|
|Estimated Study Completion Date :||August 30, 2021|
Treatment with LB100
LB-100 will be infused over 2 hours via syringe pump in the OR or 1-12 hours before to surgery. The dose established from a Phase I study will be 2.33 mg/m(2).
- Drug Level in tumor tissue [ Time Frame: Post Surgery ]To determine the pharmacokinetic properties of LB100 in Gliomas tumor tissues
- Plasma concentration and calculated LB100 [ Time Frame: 8 hours post infusion ]determine the plasma concentration and calculated PK parameters of LB100 and LB100M (endothall).
- Concentration of LG100 and its major metabolite LB100 in glioblastoma tumor tissue [ Time Frame: 8 hours post infusion ]determine the concentration LB100 and its major metabolite, 7-oxabicyclo [2.2.1] heptanes-2,3- dicarboxylic acid (LB100M) in glioma tumor tissue when a known non-toxic dose of LB100 is delivered intravenously over 2 hours
- Relationship between drug concentration at the site of action and the resulting effect and the presence of correlation to identify predictive markers. [ Time Frame: 8 hours post infusion ]Intra-patient PD effect in PBMC and tumor tissue will be evaluated in all subjects for presence of correlation to identify potential predictive markers
- Changes in phospho-protein expression in circulating PBMC [ Time Frame: 8 hours post infusion ]determine changes in phospho- protein expression in circulating PBMC
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): NCT03027388
|Contact: Matthew R Lindsley, R.N.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Eric C Burton, M.D.||National Cancer Institute (NCI)|