At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed glioblastoma/gliosarcoma, grades II-III astrocytoma, or oligodendroglioma
- ✓Recurrent disease with clinical indication for resection
- ✓Age ≥18 years
- ✓Karnofsky performance status ≥60%
- ✕Currently receiving other investigational agents
- ✕Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric illness limiting compliance
- ✕Unwilling to undergo craniotomy
- ✕Pregnant or breastfeeding women
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of LB100, a Protein Phosphatase 2A Inhibitor, in Recurrent Glioblastoma
In Brief
A Phase 2 clinical trial evaluating LB-100 for Astrocytoma, Grades II, III and IV and 4 related conditions. Completed, enrolled 7 participants across 1 site.
Detailed Summary
Background: 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. Objective: To see if LB100 can pass into the brain. Eligibility: People at least 18 years old with a brain tumor that requires surgery. Design: Participants will be screened with: Physical exam Medical history Blood tests Neurosurgery evaluation Scans Heart tests 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-three 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.
Study Details
Timeline
Interventions
LB-100 will be infused over 2 hours via intravenous (IV) infusion 2 to 4 hours before surgery. The dose established from a Phase I study will be 2.33 mg/m\^2.